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Mesotheliona Clinical Trials

In order to one day find a mesothelioma cure, doctors engage in clinical trials where they test new mesothelioma drugs to determine if they are effective.

Mesothelioma clinical trials follow a plan of very strict scientific guidelines, which is called a protocol. The protocol explains everything that will happen in the study. It must be approved by review boards made up of health care professionals and other qualified people before the study can enroll patients.

When a potential mesothelioma drug is first identified, preclinical studies, which are conducted in a laboratory setting, help to find out whether the drug is safe to test in humans. During this stage, the drug is usually studied in animals to answer questions about how a drug works and how the body changes and disposes of it. Humans do not participate in preclinical studies. There are four possible phases of cancer clinical trials in humans, each designed to answer different questions about the treatment being studied.

In Phase I mesothelioma clinical trials, doctors are primarily studying the safety of giving mesothelioma drugs to humans, while also looking for the best way to give a medication (for example, as a pill, an injection, or an infusion). They will usually study how the mesothelioma drug is eliminated from the body in humans. Also, doctors are trying to find the right doses for further testing. They carefully watch for any side effects. Phase I study drugs are usually given to small groups of humans. During this phase, for drugs used to treat mesothelioma cancer, investigators may be able to find out which tumors a treatment works best in.

In Phase II mesothelioma clinical trials, the mesothelioma drug is studied in a larger group. The primary purpose of these studies is to see how well the drug or treatment shrinks tumors in patients with specific types of cancer. The investigator will watch closely for side effects and will also watch how the disease responds to the treatment.

In Phase III mesothelioma clinical trials, the new cancer treatment is generally compared to a standard existing treatment. Patients are usually randomly assigned (that is, a process similar to flipping a coin is used to determine which treatment the patient receives) to receive either a standard treatment or the new treatment. During the trial, patients may or may not be told which treatment they are getting but are told what to expect and what to watch for. Occasionally, even the doctor will not know which treatment each patient is getting so that he or she can remain unbiased about how the disease is responding to the treatment. (This is uncommon in cancer clinical trials). Phase III studies are designed to ensure that any side effects that patients experience are identified and treated according to local standards of care.

Phase IV mesothelioma clinical trials study a drug that has already been approved by the Food and Drug Administration. Drug companies often sponsor these trials to study even more uses of drugs already available.

Note: Information about these below trials are from the ClinicalTrials.gov database:

Current Updated Clinical Trials with Contact Info

Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Trial Description

Summary

The primary objective of the study is to determine the overall 1 year survival rate of the two combined arms.

Further Study Information

Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are unsatisfactory and have not been shown to significantly prolong survival, and often lead to worsened pulmonary function and quality of life. We will investigate whether a prospective trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed treatment will include exploratory thoracoscopy, placement of Mediport catheters into the pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition, because this study is randomized, half the patients will receive an additional three intraveons systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem with their intrapleural chemotherapy (weeks 3, 6, and 9 only).

The potential significance of this research is that such treatment may render it less necessary to surgically remove the affected lungs in whole or in part, in order to achieve significant disease cytoreduction. We hope to alter the currently accepted paradigm that major lung surgery is an inescapable component of such treatment, and advance the concept that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional drug treatment of the pleural surfaces may offer the best hope for prolongation of survival with intact lung function.

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed malignant mesothelioma, < 20% sarcomatoid type

No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease.

Ineligible for other high priority national or institutional study.

Age >18 years [to physiologic 75 years].

Life expectancy > 3 months.

Trial Contact Information

Trial Lead Organizations/Sponsors

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Robert N Taub, MD, PhD: Principal Investigator

Danielle Banks: Ph: 212-305-3846 Email:

Trial Sites

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Danielle Banks:� Ph: 212-305-3846 Email:

NLM Identifer NCT00859495

Information obtained from ClinicalTrials.gov on January 20, 2011

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Trial Description

Summary

Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to disease progression or completion of therapy, patient's will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.

Further Study Information

The primary objective of this study is to determine the objective tumor response rate for VELCADE plus ELOXATIN in patients with malignant mesothelioma.

The aims of this study are to: (a)to determine the tumor response rate, median survival, time to response, duration of response and time to treatment failure or progression of disease;(b)to ascertain if in vitro assessment of gene expression profiles via PCR can be used to ascertain a patient's response to VELCADE (bortezomib) therapy (c) to characterize the quantitative and qualitative toxicities of VELCADE plus ELOXATIN in this patient population.

Each cycle of treatment is composed of 28 days and consists of four treatments with VELCADE (d 1,4,15,and 18) and two treatments with ELOXATIN (days 4,and 18). Patients will undergo a physical examination and routine blood work at each visit. A Quality of Life (QOL) assessment will be performed prior to initiating each cycle of therapy and CT scans will be performed at baseline and every 2 cycles (8 weeks)to assess tumor response.

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically confirmed malignant pleural or peritoneal mesothelioma epithelial, sarcomatoid, or mixed subtype, not amenable to curative treatment with surgery. Patients with pleural mesothelioma will be clinically staged using the IMIG's staging criteria (section 17.1). Note that there is no staging system for peritoneal mesothelioma and those patients will only be followed for survival. Patients may be entered based on local pathology.

Patients must have had ≤2 prior form of systemic chemotherapy. Prior intracavitary chemotherapy will be considered a prior regimen unless it was given for the purpose of pleurodesis. Immunomodulators will not be regarded as chemotherapy. Prior systemic treatment with pemetrexed plus cisplatin or carboplatin will not be a contraindication for treatment with VELCADE/ELOXATIN.

Disease status must be that of measurable disease as defined by modified SWOG criteria.

Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology.

Measurable lesions: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scans. At least one level must have one rind measurement ≥15 mm. CT (specifically spiral CT) scans and MRI are the preferred methods of measurement.

Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required. NOTE: Neither pleural effusions nor positive bone scans are considered measurable.

Patients may have undergone pleurodesis. If pleurodesis was recently performed, there must be at a minimum of a 2 week delay prior to treatment initiation. If a CT scan was done prior pleurodesis, a repeat CT scan for baseline evaluation will need to be performed prior to study entry. NOTE: For patients with clinically significant pleural effusions or ascites, consideration should be given to draining the fluid prior to initiating therapy.

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (after any palliative measures including pleural drainage have occurred), see section 14.2.

Patients must have an estimated life expectancy of at least 12 weeks.

Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.

Patients must have adequate organ function at the screening visit as defined by the following laboratory values: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet count ≥100 x 109/L Hemoglobin ≥9 g/dL. Albumin ≥ 2.5 g/dL Total Bilirubin ≤2.5 x ULN Alkaline phosphatase ≤3.0 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3.0 x ULN Creatinine ≤ 1.5 x ULN NOTE: total bilirubin, alkaline phosphatase, AST, ALT ≤5 x ULN acceptable if liver has tumor involvement

Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Patient must be a male or female of at least 18 years of age.

Female subjects must either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.

Male subjects must agree to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

Has active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 3).

Has experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality noted should be documented by the investigator as not medically relevant.

Has been treated previously with VELCADE or ELOXATIN.

Has had prior radiation therapy to the target lesion, unless the lesion is clearly progressing and the interval between the most recent radiation therapy and enrollment is at least 4 weeks.

Has uncontrolled active systemic infection requiring therapy.

Has a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.

Female subject is pregnant or breast-feeding.

Has had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).

Has had a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.

Has had any investigational agent within 4 weeks prior to enrollment into this study.

Is unwilling to employ adequate means of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, or abstinence).

Has disease which cannot be radiologically imaged.

Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Trial Contact Information

Trial Lead Organizations/Sponsors

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Robert N Taub, MD, PhD:� Principal Investigator

Danielle Banks: Ph: 212-305-3846 Email:

Trial Sites

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Danielle Banks:� Ph: 212-305-3846 Email:

Robert N. Taub: Principal Investigator

Alain C Borczuk, MD:� Sub-Investigator

Charles A. Powell:� Sub-Investigator

NLM Identifer NCT00996385

Information obtained from ClinicalTrials.gov on October 18, 2010

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Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

Trial Description

Summary

The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

Further Study Information

This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.

Eligibility Criteria

Inclusion Criteria:

Males and females > 18 years of age

Life expectancy of at least 2 months

Histologically confirmed unresectable malignant pleural mesothelioma (MPM)

Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening

ECOG Performance Status of 0-2

Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:

1. ANC ≥ 1.5 x 109/L

2. Platelet Count ≥ 100 x 109/L

3. Hemoglobin ≥ 9g/dL

4. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

5. AST ≤ 2.5 x ULN

6. ALT ≤ 2.5 x ULN

7. ALK-P ≤ 3 x ULN

8. Serum creatinine ≤ 1.8mg/dL

9. Calculated Serum Creatinine Clearance 40 - > 60ml/min

Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.

Willing and able to provide written informed consent.

Exclusion Criteria:

Known central nervous system (CNS) tumor involvement

Evidence of other active malignancy requiring treatment

Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)

Known infection with HIV or hepatitis

Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.

Active, serious systemic disease, including active bacterial or fungal infection.

Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.

Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.

Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.

Trial Contact Information

Trial Lead Organizations/Sponsors

UAB Comprehensive Cancer Center

Novartis Pharmaceuticals Corporation

Francisco Robert:� Principal Investigator

Mary L. Jerome, RN:� Ph: 205-934-5092 Email:

Alma F. DelGrosso, RN, BSN, OCN: Ph: 205-934-0337 Email:

Trial Sites

Alabama
Birmingham
UAB Comprehensive Cancer Center

Mary L. Jerome, RN:� Ph: 205-934-5092 Email:

Alma F. DelGrosso, RN, BSN, OCN:� Ph: 205-934-0337 Email:

Francisco Robert:� Principal Investigator

NLM Identifer NCT01204203

Information obtained from ClinicalTrials.gov on October 26, 2010

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Intrapleural Gene Transfer for Pleural Mesothelioma

Trial Description

Summary

This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.

Further Study Information

Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart in subjects with pleural mesothelioma.

Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation. Subjects are then followed-up as outpatients for a total of 6 months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural catheter is removed once it is not necessary.

Eligibility Criteria

Inclusion Criteria:

evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma

evaluable disease

No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector

Must have a pleural space involved with tumor accessible for pleural catheter insertion

FEV1> 1 liter or 40% of predicted value

Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. This will be measured by the Penn Vector Core

Exclusion Criteria:

Presence of HIV or Hepatitis B infection

Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system

Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease

Presence of untreated brain metastases

Prior bone marrow or stem cell transplants

Trial Contact Information

Trial Lead Organizations/Sponsors

Abramson Cancer Center of the University of Pennsylvania

National Cancer Institute

Daniel H. Sterman:� Principal Investigator

Adri Recio, RN, BA: Ph: 215-573-6760 Email:

Joan Gilmore, BS: Ph: 215-746-8902 Email:

Trial Sites

Pennsylvania
Philadelphia

Abramson Cancer Center of the University of Pennsylvania

Adri Recio, RN, BA:� Ph: 215-573-6760 Email:

Daniel H. Sterman:� Principal Investigator

NLM Identifer NCT01212367

Information obtained from ClinicalTrials.gov on October 18, 2010

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Dasatinib in Resectable Malignant Pleural Mesothelioma

Trial Description

Summary

Primary Objectives:

The primary objective of this novel phase I trial will be the level of biomarker modulation of p-Src Tyr 419 by induction dasatinib therapy in patients with resectable malignant pleural mesothelioma.

Secondary Objectives:

Secondary objectives include overall and progression-free survival, tumor radiographic and pathologic response, and safety-toxicity profiles. Exploratory analyses will include additional biomarker evaluation in pre- and post-treatment tumor specimens, and serum/platelet/pleural effusion biomarker modulation.

Further Study Information

The Study Drug:

Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This may cause the tumor cells to die.

Screening Tests:

Before you can start taking the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

Your complete medical history will be recorded.

You will have a physical exam, including measurement of vital signs (temperature, blood pressure, pulse, and breathing rate) and weight. You will also have a test to check the amount of oxygen in your blood.

Blood (about 3-4 teaspoons) will be drawn for routine tests.

You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).

You will have an electrocardiogram (ECG--a test that measures the electrical activity of the heart).

Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots.

You will have a positron emission tomography (PET) scan to check the status of the disease.

Women who are able to have children must have a negative blood (about 1-2 teaspoons) or urine pregnancy test.

Before you begin taking dasatinib, you will also be tested to check the status of the disease and to help the doctor decide which type of surgery you will have. You will have a laparoscopy, mediastinoscopy, bronchoscopy, and either a video-assisted thoracoscopy or intraoperative ultrasound-guided core biopsy. You will be given a separate consent for each of these procedures, which will describe the procedures and any risks in detail.

Laparoscopy is a surgical procedure that uses a thin, lighted tube put through a cut (incision) in the belly to look at the abdominal organs or the female pelvic organs.

Mediastinoscopy is a surgical procedure to examine the inside of the upper chest between and in front of the lungs (mediastinum). During a mediastinoscopy, a small incision is made in the neck just above the breastbone or on the left side of the chest next to the breastbone. Then a thin scope (mediastinoscope) is inserted through the opening. A tissue sample (biopsy) can be collected through the mediastinoscope and then examined under a microscope for lung problems, such as infection, inflammation, or cancer.

Video-assisted thoracoscopy (VATS) is a procedure to take a biopsy of lung tissue through a small incision between two ribs with the aid of a thin, lighted tube (videoscope) and small surgical instruments.

For the intraoperative ultrasound-guided core biopsy of the lung, subcutaneous, and/or lymph node biopsy, a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe. The needle is guided while being viewed by the physician on a computed tomography (CT) scan. Any site that can be safely biopsied will be considered for the collection of tissue.

For a bronchoscopy, you will be given drugs to relax, and then a local anesthetic will be sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. A small brush will be fed through the tube and into your lungs. The brush will gently scrape off a sample of lung tissue. Tweezers will then be fed through the tube to collect the tissue samples. A small amount of water will be sprayed into your lungs and then suctioned out through the tube to collect additional tissue samples.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take 2 dasatinib tablets by mouth 2 times a day for the 4 weeks before surgery (in the morning and 12 hours later). Dasatinib may be taken with or without food, but should be swallowed with at least 1 cup (8 ounces) of water. A light meal is not required, but may help you avoid getting a stomach ache when you take your dose. Tablets must be swallowed whole and may not be broken. If vomiting occurs within 30 minutes of swallowing the tablet(s), you can take another dose. If you miss a dose of dasatinib, take it as soon as you remember on the same day. If you miss taking your dose for 12 hours, take your regular dose the next scheduled day (do not take double your regular dose to make up for the missed dose). You will be given a "pill diary" to write down when you take the study drug. You will be shown how to fill it out and asked to bring the diary with you to each clinic visit.

Study Visits:

On Days 7, 14, 21, and 28, the following tests and procedures will be performed:

You will have a physical exam, including measurement of vital signs and weight.

You will also have a test to check the amount of oxygen in your blood.

Blood (about 3-4 teaspoons) will be drawn for routine tests.

You will have a performance status evaluation.

You will have an ECG.

Blood (about 1-2 teaspoons) will be drawn to check your how well your blood clots.

You will have a PET scan to check the status of the disease. This PET scan will be before your surgery, the study doctor will tell you when this will be performed.

Surgery:

After you have taken dasatinib for 28 days, you will have surgery to remove the tumor. You will continue to take the dasatinib until midnight the night before the surgery. Depending on the status of the disease, you will have either a pleurectomy or extrapleural pneumonectomy. You will be given a separate consent for these procedures, which will describe the surgery and any risks in detail.

Pleurectomy is the surgical procedure to remove the parietal pleura (the outermost lining around the lungs).

An extrapleural pneumonectomy is a surgical procedure that removes portions of the lung, the parietal pleura (the lining of the lung), the pericardium (the lining of the heart), and the diaphragm.

During surgery, 5-6 core biopsies, if possible, will be taken from different areas of the tumor for biomarker testing.

For the CT-guided core biopsy of the lung, a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe. The needle is guided while being viewed by the physician on a CT scan.

Length of Study:

After surgery, your doctor will decide the type of treatment you should receive for your condition. If the disease responded well to the 4 weeks of dasatinib, you may be eligible to continue taking dasatinib once a day starting 4-6 weeks after your surgery. The doctor may also decide that you can take dasatinib once a day starting 4-6 weeks after receiving radiation therapy. You may continue to take dasatinib as long as you are benefitting. You will be taken off study if intolerable side effects occur or the disease gets worse.

Follow-up Visits:

If you continue to receive the study drug after surgery, you will have a physical exam and a PET scan every 8 weeks.

If you are taken off study for any reason, you will return to the clinic once a month for 3 months and every 3 months for 2 years, for the following tests and procedures:

You will have a physical exam, including measurement of vital signs.

Blood (about 1-2 teaspoons) will be drawn for routine tests.

You will have a PET/CT.

This is an investigational study. Dasatinib is an investigational agent and ongoing clinical trials are using this drug in malignant mesothelioma. However, these studies have only recently started, and there is no information so far that shows the drug is effective in malignant mesothelioma. Dasatinib is FDA approved and commercially available for the treatment of acute lymphoid and chronic myeloid leukemia. However, its use in this research study is investigational. Up to 24 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria

Inclusion Criteria:

1. Patients with potentially resectable malignant pleural mesothelioma, IMIG stage I-III

2. Subject, age >/= 18 years

3. Any patient who is able to tolerate general anesthesia for the extended surgical staging and the definitive surgical resection.

4. No prior chemotherapy for mesothelioma within the last 3 years

5. No prior radiation to the area of primary disease. Radiation to chest wall port sites is acceptable.

6. No prior targeted biologic therapy (i.e. EGFR inhibitors, VEGF inhibitors) within the last 3 years

7. Adequate Organ Function: a) Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN), b) Hepatic enzymes (AST, ALT ) </= 2.5 times the institutional ULN, c) Serum Na, K+, Mg2+, Phosphate and Ca2+>/= Lower Limit of Normal (LLN), d) Serum Creatinine < 1.5 time the institutional ULN, e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1

8. Ability to take oral medication (dasatinib must be swallowed whole)

9. Women of childbearing potential (WOCBP) must have: A negative serum or urine pregnancy test (sensitivity </= 25IU HCG/L) within 72 hours prior to the start of study drug administration

10. Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped

11. Signed written informed consent including HIPAA according to institutional guidelines

Exclusion Criteria:

1. Malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years.

2. Prior therapies to be excluded: any prior chemotherapy or targeted biologic therapy for mesothelioma used within the last 3 years

3. Concurrent medical condition which may increase the risk of toxicity, including: a) Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease) b) Any disease which requires persistent anticoagulation therapy (and the patient may not be taken off the anti-coagulation safely) with coumadin, factor Xa inhibitors, or heparin (low-molecular weight, standard)

4. Cardiac Symptoms, consider the following: a) Uncontrolled angina, congestive heart failure or MI within (6 months), b) Diagnosed congenital long QT syndrome: 1. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), 2. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), 3. Subjects with hypokalemia or hypomagnesemia if it cannot be corrected

5. History of significant bleeding disorder unrelated to cancer, including: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), b) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), c) Ongoing or recent (</= 3 months) significant gastrointestinal bleeding

6. Concomitant Medications, consider the following prohibitions: a) Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib): A) quinidine, procainamide, disopyramide, B) amiodarone, sotalol, ibutilide, dofetilide, C) erythromycin, clarithromycin, D) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide E) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. F) moxifloxacin, levofloxacin

7. The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended.The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.a)Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy,b)Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia,c)Patient may not be receiving any prohibited CYP3A4 inhibitors,d)Patient may not be receiving any alternative herbal remedies during the dasatinib treatment period

8. Women: a) are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or, b) have a positive pregnancy test at baseline, or c) are pregnant or breastfeeding, d) Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.,

9. -continued from exclusion #8-: e) Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy., f) All WOCBP MUST have a negative pregnancy test prior to first receiving dasatinib. If the pregnancy test is positive, the patient must not receive dasatinib and must not be enrolled in the study.

10. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Bristol-Myers Squibb Company - New York

Department of Defense

Anne S. Tsao, MD:� Principal Investigator

Anne S. Tsao, MD:� Ph: 713-792-6363

James Gil, RN: Ph: 713-745-6766

Trial Sites

Texas
Houston

M. D. Anderson Cancer Center at University of Texas

Anne S. Tsao, MD: Principal Investigator

NLM Identifer NCT00652574

Information obtained from ClinicalTrials.gov on November 18, 2010

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An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

Trial Description

Summary

Milataxel is a new taxane that may have several advantages over the currently available taxanes. The current study is designed to determine the response rate of oral Milataxel in patients with malignant Mesothelioma. The study specifically targets patients who have recurring or progressive disease following previous chemotherapy.

Further Study Information

This is a non-randomized, multicenter, open label, single agent phase II study. Patients with malignant mesothelioma that has recurred or progressed following chemotherapy, and who qualify for this study, will receive milataxel 60 mg/m2 orally on Day 1 of a 21 day cycle. If no toxicities of greater than Grade 1 severity occur, patients will receive 75 mg/m2 for the second and subsequent cycles. Patients will receive drug for a total of six cycles. Milataxel administration in excess of six cycles will be permitted at the discretion of the Investigator if patients have stable or responding disease.

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically or cytologically confirmed malignant mesothelioma for which they have received pemetrexed in combination with cisplatin as part of chemotherapeutic regimen.

Prior cancer therapy with pemetrexed/cisplatin must have been completed at least 30 days prior to the first cycle of milataxel; prior radiotherapy (less than 25% of the bone marrow) must have been completed at least 30 days prior to study enrollment.

Patients must have measurable disease by the Modified RECIST criteria

Patients must have a life expectancy of at least 12 weeks and an ECOG performance status of 0, 1 or 2

Patients must be 18 years of age.

Patients must have adequate organ and system function.

Patients must be able to comply with the protocol treatments and procedures.

Patients with known brain metastases may be included in the study, providing they are clinically stable.

Recovered from all acute toxicities caused by prior cancer therapies, except for alopecia.

Exclusion Criteria:

Patients must not have received any other chemotherapeutic treatment for malignant mesothelioma other than pemetrexed and a platinum agent such as cisplatin.

Patients with grade 2 or greater peripheral neuropathy.

Prior cancer therapies not completed within 30 days prior to the first cycle of milataxel; radiotherapy completed less than 30 days prior to study enrollment; patients not recovered from radiation-related toxicities; patients receiving any concurrent anti-cancer therapy, including trastuzumab, bevacizumab or an investigational agent while on-study; patients with greater than 2 prior radiotherapy treatments.

Patients with known sensitivity to alcohol.

Patients with significant intercurrent illnesses.

Patients with symptomatic CNS metastases.

Patients who have had major surgery within the past 14 days.

Patients who require or are likely to require any strong modifier of CYP450 activity to be taken prior to milataxel administration

Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).

Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or major resection of the stomach or small bowel that could affect absorption of the study drug.

Women who are pregnant or breastfeeding.

Trial Contact Information

Trial Lead Organizations/Sponsors

Taxolog, Incorporated - New Jersey

Harvey Pass, M.D.:� Principal Investigator

Harvey Pass, M.D.: Ph: (212)731-5414 Email:

Trial Sites

Illinois
Chicago

University of Chicago Cancer Research Center

Sarah Mauro:� Ph: 773-834-3263 Email:

Hedy L. Kindler:� Principal Investigator

New York

NYU Cancer Institute at New York University Medical Center

Harvey Pass, M.D.:� Ph: 212-731-5414 Email:

NLM Identifer NCT00685204

Information obtained from ClinicalTrials.gov on October 18, 2010

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Phase II Study of Everolimus in Patients With Unresectable Malignant Pleural Mesothelioma

Trial Description

Purpose:

Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

This phase II trial is studying how well everolimus works in treating patients with pleural malignant mesothelioma that cannot be removed by surgery.

Eligibility:

Eligibility criteria include the following:

At least 18 years old

Received previous cisplatin, carboplatin, or oxaliplatin

No CNS metastases

At least 4 weeks since systemic therapy or surgery

At least 2 weeks since radiation therapy

No previous rapamycin, everolimus, or temsirolimus

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive everolimus by mouth once a day. Treatment may continue for as long as benefit is shown.

After finishing treatment, patients will be evaluated for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Sai-Hong Ou, MD, PhD, Protocol chair:� Ph: 714-456-8104 Email: siou@uci.edu

Linda Garland, MD, Protocol co-chair:� Ph: 520-626-3434; 800-622-2673 Email: lgarland@azcc.arizona.edu

Trial Sites

Arizona
Tucson

Arizona Cancer Center at University of Arizona Health Sciences Center

Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center

Ph:� 520-626-9008

California
Los Angeles

USC/Norris Comprehensive Cancer Center and Hospital

Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital

Ph:� 323-865-0451

Marysville

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Ph: 916-734-3772: David Gandara, MD

Orange

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Clinical Trials Office - Chao Family Comprehensive Cancer Center

Ph: 877-UC-STUDY Email: ucstudy@uci.edu

Pleasanton

Valley Medical Oncology Consultants � Pleasanton

David Gandara, MD: 916-734-3772

Sacramento

University of California Davis Cancer Center

Clinical Trials Office - University of California Davis Cancer Center

Ph:� 916-734-3089

Colorado

Aurora

University of Colorado Cancer Center at UC Health Sciences Center

Clinical Trials Office - University of Colorado Cancer Center Ph: 720-848-0650

Edwards

Shaw Regional Cancer Center

Ana Oton Ph: 970-569-7429

Glenwood Springs

Valley View Hospital Cancer Center

Ana Oton: Ph: 970-945-6535

Montrose

Montrose Memorial Hospital Cancer Center

Clinical Trials Office - Montrose Memorial Hospital Cancer Center

Ph:� 670-240-7267

Connecticut
Hartford

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Philip Stella, MD: Ph:� 734-712-1000

Georgia
Gainesville

Northeast Georgia Medical Center

Charles Nash, MD: Ph:� 770-297-5700

Illinois
Decatur

Decatur Memorial Hospital Cancer Care Institute

Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute

Ph:� 217-876-4750

Naperville

Edward Hospital Cancer Center

Clinical Trials Office - Edward Hospital Cancer Center: Ph: 630-646-6075

Springfield

Regional Cancer Center at Memorial Medical Center

Clinical Trials Office - Regional Cancer Center at Memorial Medical Center: Ph:� 217-788-4233

Indiana
Beech Grove

St. Francis Hospital and Health Centers - Beech Grove Campus

Howard Gross, MD: 937-832-1093

Richmond

Reid Hospital & Health Care Services

Howard Gross, MD:� Ph: 937-832-1093

Kansas
Chanute

Cancer Center of Kansas, PA � Chanute

Shaker Dakhil, MD, FACP:� Ph: 316-262-4467

Dodge City

Cancer Center of Kansas, PA - Dodge City

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

El Dorado

Cancer Center of Kansas, PA - El Dorado

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Independence

Cancer Center of Kansas-Independence

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Kingman

Cancer Center of Kansas, PA � Kingman

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Lawrence

Lawrence Memorial Hospital

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Liberal

Cancer Center of Kansas, PA � Liberal

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Newton

Cancer Center of Kansas, PA � Newton

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Parsons

Cancer Center of Kansas, PA � Parsons

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Pratt

Cancer Center of Kansas, PA � Pratt

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Salina

Cancer Center of Kansas, PA � Salina

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Wellington

Cancer Center of Kansas, PA � Wellington

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Wichita

Associates in Womens Health, PA - North Review

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Cancer Center of Kansas, PA � Wichita

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Cancer Center of Kansas, PA - Medical Arts Tower

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

CCOP � Wichita

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Via Christi Cancer Center at Via Christi Regional Medical Center

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Winfield

Cancer Center of Kansas, PA � Winfield

Shaker Dakhil, MD, FACP: Ph: 316-262-4467

Michigan

Ann Arbor

CCOP - Michigan Cancer Research Consortium

Philip Stella, MD: Ph: 734-712-1000

Saint Joseph Mercy Cancer Center

Philip Stella, MD: Ph: 734-712-1000

University of Michigan Comprehensive Cancer Center

Clinical Trials Office - University of Michigan Comprehensive Cancer Center Ph: 800-865-1125

Dearborn

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center

Ph: 313-593-8090

Detroit

Barbara Ann Karmanos Cancer Institute

Clinical Trials Office - Barbara Ann Karmanos Cancer Institute Ph: 313-576-9363

Flint

Genesys Hurley Cancer Institute

Clinical Trials Office - Genesys Hurley Cancer Institute Ph: 810-762-8057

Hurley Medical Center

Clinical Trials Office - Hurley Medical Center Ph: 810-762-8057

Grosse Pointe Woods

Van Elslander Cancer Center at St. John Hospital and Medical Center

Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center

Ph: 313-343-3166

Jackson

Foote Memorial Hospital

Philip Stella, MD: Ph: 734-712-1000

Lansing

Sparrow Regional Cancer Center

Clinical Trials Office - Sparrow Regional Cancer Center Ph: 517-364-2890

Livonia

St. Mary Mercy Hospital

Philip Stella, MD Ph: 734-712-1000

Pontiac

St. Joseph Mercy Oakland

Philip Stella, MD: Ph: 734-712-1000

Port Huron

Mercy Regional Cancer Center at Mercy Hospital

--------------------------------------------------------------------------------------------------------------------------

Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

Trial Description

Summary

RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is currently used safely as in intra-operative treatment for malignant pleural mesothelioma. This study is aimed to determine if the addition of gemcitabine as a second intracavitary chemotherapy can be accomplished safely.

PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting of gemcitabine and cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees Celsius and the effect of cytoprotection agents: amifostine and sodium thiosulfate to counteract potential side effects of chemotherapy.

Further Study Information

This is a dose escalation study of gemcitabine with a fixed dose of cisplatin

Patients will undergo cytoreductive surgery, which entails the removal of the inner and outer lining of the lung (pleurectomy/decortication) with or without the lung itself (extrapleural pneumonectomy), including the lining overlying the pericardium and diaphragm. Resection of the pericardium and diaphragm are occasionally necessary to remove all visable tumor. This surgery is part of standard care for malignant pleural mesothelioma.

After surgery, a one hour lavage with heated cisplatin and or gemcitabine will be administered to the hemithorax (and abdominal regions if the diaphragm is no longer present).

Patients will remain hospitalized until they have recovered from surgery (usually 7-14 days).

Patients will return to the hospital during the first month after their surgery to be evaluated by the medical staff.

Dose escalation: 1) Three patients will be treated at the first dose level of gemcitabine. Labs will be monitored on a weekly basis, including a CBC, Chem-7, and LFT's. In the absence of developing dose-limiting toxicity (DLT) among the first 3 patients treated, dosages can be escalated. DLT will be defined as any grade 3 or higher renal toxicity, thrombocytopenia or other grade 3 toxicity not related to surgery 2) If none of these 3 patients have any toxicity, we will proceed to the next level of gemcitabine. 3) If DLT occurs in 1 of 3 patients at a given dose level, then 3 additional patients are added at that dose (for a total of 6 at this level)If no DLT occurs, we will proceed to the next level of gemcitabine. If DLT occurs in another patient, this dose is considered the maximum tolerated dose (MTD). 4) At any dose, 3 cases of DLT lead to discontinuation of recruitment at that dose and enrollment of 3 additional patients at a lower dose.

Eligibility Criteria

Inclusion Criteria:

Histologically-proven diagnosis of stages I to III malignant mesothelioma of the pleura and negative mediastinal N2 lymph nodes (Malignancy is confined to the affected hemithorax) Adequate organ function including the following: adequate cardiac function, pulmonary function, renal and hepatic function and bone marrow reserve

Adequate overall physical activity

Surgical candidate for cytoreductive surgery

Exclusion Criteria:

Extended disease outside the ipsilateral hemithorax as proven histologically, radiologically and/or intraoperatively

Have received chemotherapy and or radiation therapy within the last 3 years at the time of study entry

Serious concomitant systemic disorders

Second active primary malignancy (to exclude non- melanoma skin cancer)

Pregnancy at the time of the operation

Psychiatric or addictive disorder which would preclude obtaining informed consent

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Brigham and Women's Cancer Center

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

David J. Sugarbaker:� Principal Investigator

David Sugarbaker, M.D.:� Ph: 617-732-5004 Email:

Tamara Tilleman, M.D, PhD:� Ph: 617-732-5079 Email:

Trial Sites

Massachusetts
Boston

Dana-Farber/Brigham and Women's Cancer Center

David J. Sugarbaker:� Principal Investigator

NLM Identifer NCT00571298

Information obtained from ClinicalTrials.gov on October 18, 2010

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Phase I Study of SS1(dsFv)-PE38 Immunotoxin in Combination With Pemetrexed Disodium and Cisplatin in Patients With Unresectable Malignant Epithelial Pleural Mesothelioma

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Trial Description

Purpose:

Immunotoxins can find tumor cells and kill them without harming normal cells. Drugs used in chemotherapy, such as pemetrexed and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with immunotoxin therapy may kill more malignant mesothelioma cells.

This phase I trial is studying the side effects and best dose of immunotoxin therapy when given together with pemetrexed and cisplatin in treating patients with malignant pleural mesothelioma that cannot be removed by surgery.

Eligibility:

Eligibility criteria include the following:

At least 18 years old

No biphasic tumors with a predominantly sarcomatoid component

Alternate Title

Measurable disease

More than 4 weeks since biological therapy for malignant mesothelioma

More than 2 weeks since surgery or pleurodesis

No previous systemic chemotherapy for malignant mesothelioma

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of the immunotoxin on days 1, 3, and 5; an infusion of pemetrexed on day 1; and a 2-hour infusion of cisplatin on day 1 of courses one and two. Beginning with course three, patients will receive an infusion of pemetrexed and a 2-hour infusion of cisplatin on day 1. Treatment may repeat every 3 weeks for as long as benefit is shown.

Patients will undergo blood sample collection periodically for laboratory studies. Previously collected tumor cells will also be studied in the laboratory.

Patients will fill out quality of life questionnaires periodically. After finishing treatment, patients will be evaluated periodically for 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Raffit Hassan, MD, Principal investigator: Ph: 301-451-8742

Trial Sites

Maryland

Bethesda

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office

Ph: 888-NCI-1937

Related Information

Featured trial article

Registry Information

Official Title: A Phase I, Single Center, Dose-Escalation Study of SS1(dsFv)PE38 Administered Concurrently with Pemetrexed and Cisplatin in Subjects with Unresectable Malignant Epithelial Pleural Mesothelioma

Trial Start Date: 2007-06-01

Trial Completion Date: 2009-06-01 (estimated)

Registered in ClinicalTrials.gov: NCT00575770

Date Submitted to PDQ: 2007-11-29

Information Last Verified: 2008-03-30

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Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (0683-014 AM5, EXT1)

Trial Description

Summary

This is a study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug, suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural mesothelioma.

Further Study Information

Treatment Extension Phase: Participants in this study will be eligible to enroll in an open-label treatment extension phase if they: a) were originally randomized to the vorinostat arm and have not experienced disease progression; b) were randomized to the placebo arm and meet the "Extension Phase Inclusion Criteria for Participants in the Placebo Arm" below; or c) were originally randomized to the vorinostat arm and discontinued study therapy for reasons other than progression and the investigator believes that it is in the participant's best interest to resume vorinostat treatment.

Eligibility Criteria

Inclusion Criteria :

Participant must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma

In countries where pemetrexed an approved mesothelioma treatment, the participant's disease has progressed or relapsed following treatment with at least one prior chemotherapy regimen with pemetrexed and either cisplatin or carboplatin OR In countries where pemetrexed is not approved for mesothelioma, the participant's disease has progressed or relapsed following treatment with at least one prior chemotherapy regimen OR Pemetrexed is not the preferred therapy for the participant and the participant's disease has progressed or relapsed following treatment with at least one prior chemotherapy regimen

Participants must have received no more than 2 prior systemic therapy regimens

Participant has a Karnofsky performance scale status of ≥70

Participant must have adequate bone marrow, liver, and kidney function and adequate coagulation (per prespecified laboratory values)

Extension Phase Inclusion Criteria:

Participants who are receiving treatment with vorinostat and have not experienced progression of mesothelioma

Participants who were randomized to the placebo arm and are: 1) have a Karnofsky performance scale status of ≥70; and 2) have adequate bone marrow, liver, and kidney function and adequate coagulation (per prespecified laboratory values)

Participants assigned to vorinostat who have discontinued study therapy for reasons other than progression of mesothelioma, if the investigator is of the opinion that the potential benefit outweighs potential risks associated with using vorinostat

Exclusion Criteria :

Participant has been treated with a Histone deacetylase [HDAC] inhibitor

Participant has an active infection for which they received treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug.

Participants with a "currently active" second malignancy. A malignancy is not considered "currently active" if participants have completed therapy for the second malignancy and are disease free from prior malignancies for >5 years

Participant has uncontrolled brain metastases

Participant has a known human immunodeficiency virus (HIV) infection or HIV-related malignancy

Participant is pregnant or breast feeding

Participant has a history of gastrointestinal surgery or other procedures that might interfere with the absorption or swallowing of the study drug

Participants taking part in the pre-dose spot and post-first dose 24-hour urine collections must exclude medications containing acetominophen or paracetamol for one week prior to the start of vorinostat therapy and during the entire period of urine collection

Participants taking part in the pre-dose spot and post-first dose 24-hour urine collections may not be using hemodialysis or peritoneal dialysis

Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

Toll Free Number: 1-888-577-8839 Call for Information

Trial Sites

Colorado
Denver

Illinois
Chicago

Gurnee

Maryland
Annapolis

Michigan
Southfield

New York

Pennsylvania
Philadelphia
Pittsburgh

Texas
Houston

NLM Identifer NCT00128102

Information obtained from ClinicalTrials.gov on February 15, 2011

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Phase I/II Randomized Study of Pemetrexed Disodium and Cisplatin With Versus Without Cediranib Maleate in Patients With Malignant Pleural Mesothelioma

Trial Description

Purpose:

Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.

This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and tp see how well it works in treating patients with malignant pleural mesothelioma.

Eligibility:

Eligibility criteria include the following:

At least 18 years old

Not planning to undergo surgery to remove the tumor

No previous pemetrexed disodium, cisplatin, or cediranib maleate

Alternate Title

At least 4 weeks since surgery or radiation therapy

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Some patients will receive an infusion of pemetrexed disodium and a 2-hour infusion of cisplatin in week 1. They will also receive cediranib maleate by mouth once a day for 3 weeks. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive cediranib maleate by mouth alone once a day for as long as benefit is shown.

Other patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive an infusion of pemetrexed disodium and a 2-hour infusion of cisplatin in week 1. They will also receive cediranib maleate by mouth once a day for 3 weeks. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive cediranib maleate by mouth alone once a day for as long as benefit is shown.

Patients in group two will receive an infusion of pemetrexed disodium and a 2-hour infusion of cisplatin in week 1. They will also receive a placebo by mouth once a day for 3 weeks. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive a placebo by mouth alone once a day for as long as benefit is shown.

After finishing treatment, patients will be evaluated periodically for up to 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Anne Tsao, MD, Principal investigator: Ph: 713-792-6363; 800-392-1611

Trial Sites

Arkansas
Bentonville

Highlands Oncology Group � Springdale

Joseph Beck, MD, FACP: Ph: 479-587-1700

Kentucky
Lexington

Lucille P. Markey Cancer Center at University of Kentucky

Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center

Ph: 859-257-3379

Michigan
Ann Arbor

University of Michigan Comprehensive Cancer Center

Clinical Trials Office - University of Michigan Comprehensive Cancer Center: Ph: 800-865-1125

Texas
Houston

M. D. Anderson Cancer Center at University of Texas

Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas: Ph: 713-792-3245

Registry Information

Official Title: A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma

Trial Start Date: 2010-05-12

Trial Completion Date: 2011-03-01 (estimated)

Registered in ClinicalTrials.gov: NCT01064648

Date Submitted to PDQ: 2010-02-01

Information Last Verified: 2011-02-09

NCI Grant/Contract Number: CA32102

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Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity

Trial Description

Summary

For patients with malignant pleural mesothelioma that has grown despite treatment with standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus works by blocking a protein that helps the cancer grow. The goal of this clinical research study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma. The safety of this drug will also be studied. The patients' physical state, changes in the size of the tumor, and laboratory findings taken during the study will help us decide if everolimus is safe and effective.

Eligibility Criteria

Inclusion Criteria:

Patients must have a histologically confirmed diagnosis of epithelioid, sarcomatoid, or mixed-type malignant pleural mesothelioma that is not amenable to surgery.

Patients must have measurable disease according to the modified RECIST criteria for mesothelioma.

Patients must have adequate tissue sample available for analysis of NF2/Merlin loss. (archived tissue block or 10 unstained slides)

Patients must have received no more than two prior systemic therapy regimens, and at least one of the regimens must have included pemetrexed.

Patients must be at least 18 years of age.

Karnofsky performance status > or = to 70%.

Adequate renal function: serum creatinine ≤ 1.5 x ULN.

Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.

Signed informed consent

Patients must have adequate hepatic function as defined by:

AST and ALT ≤ 2.5 x ULN (≤ 5x ULN in patients with liver metastases)

Serum bilirubin ≤ 1.5 x ULN

Patients must have adequate bone marrow function as defined by:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

Platelets ≥ 100 x 109/L

Hemoglobin ≥ 9 g/dL

Exclusion Criteria:

Patient has been previously treated with an mTOR inhibitor (sirolimus, temsirolimus, or everolimus).

Patients currently receiving anticancer therapies or who have received anticancer therapies within 3 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody-based therapy, etc.)

Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study

Prior treatment with any investigational drug within the preceding 4 weeks

Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed

Patients should not receive immunization with attenuated live vaccines within one week of study entry.

Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

Symptomatic congestive heart failure of New York heart Association Class III or IV

unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

uncontrolled diabetes as defined by fasting serum glucose > or = to 1.5 x ULN

Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis

Severely impaired lung function as evidenced by:

o Spirometry and/or DLCO that is ≤ 50% of the normal predicted value and/or O2 saturation that is ≤ 88% at rest on room air

A known history of HIV seropositivity

Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)

Patients with an active, bleeding diathesis

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)

Patient has an active infection for which they received IV antibiotic, antiviral, or antifungal medications within 2 weeks of starting study drug.

Patients with a "currently active" second malignancy.

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Novartis Pharmaceuticals Corporation

Lee M. Krug:�� Principal Investigator