Mesothelioma Clinical Trials
A mesothelioma diagnosis is a serious one, but it is not one without hope. There are a variety of treatments available, and a number of ongoing clinical trails.
Trial Status
We do our best to keep the current status (closed, currently recruiting, upcoming) of each clinical trial up-to-date. Several clinical trials are listed at ClinicalTrials.gov as "currently recruiting" despite the estimated completion date having been long past. The contact for a particular clinical trial is your best bet to discover if a particular clinical trial is still open and recruiting.
Glossary
To help you as you read through these clinical trials, we have glossary of terms and their definitions. Words underlined with a dashed line are part of the glossary; to see their definition, simply click on the word.
Clinical Trials
Purpose: The purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Pemetrexed has been widely used for treatment of certain solid organ tumors and is effective and approved for use in treatment of lung cancer and mesothelioma.
- Arm: Experimental: Combination therapy with OSI and Pemetrexed
- Drug: OSI-906 and Pemetrexed
- Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability.
- OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1.
Purpose This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.
- Arms: Experimental: Amatuximab infusion
- Assigned Interventions
- Drug: Amatuximab: Subjects will receive one low dose (50mg) infusion of amatuximab followed by an infusion of radiolabeled amatuximab.
- Other Names:
- MORAb-009
- MORAB-009-006
Purpose: The purpose of this study is to find out what effects a new drug PF-03446962 has on cancer. In addition, this study will look at the side effects of PF-03446962.
Purpose:
- Background:
- Mesothelin is a protein on the lining of the lungs, heart, and abdomen. It is often present at higher levels on some cancer cells. Anticancer drugs given directly to cells with high mesothelin levels may help destroy the cancer cells with fewer effects on healthy cells. BAY 94-9343 combines an anticancer drug with a type of protein that targets mesothelin. Researchers want to see if BAY 94-9343 can treat advanced cancers that have mesothelin on the cells.
- Objectives:
- To test the safety and effectiveness of BAY 94-9343 on advanced solid tumors.
- Eligibility:
- Individuals at least 18 years of age who have advanced solid tumors that have mesothelin on the cells.
- Design:
-
- Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and imaging studies. Heart and lung function tests and an eye exam will also be included.
- The study drug will be given in 3-week cycles of treatment. At the start of each cycle, participants will have BAY 94-9343 as an infusion for about 1 hour.
- Treatment will be monitored with frequent blood tests, heart and lung function tests, and imaging studies. Treatment will continue as long as the tumor does not start growing and no severe side effects develop.
Purpose: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Approximately 51 to 75 subjects will be enrolled.
- Arms
-
- Cohort A: Experimental
- ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
- Intervention: Drug: ABT-700
- Cohort B: Experimental
- ABT-700 plus erlotinib 150 mg qd (21-day cycle).
- Intervention: Drug: ABT-700 plus erlotinib
- Cohort C: Experimental
- ABT-700 plus oxaliplatin and capecitabine. ABT-700 IV (Day 1) Oxaliplatin: 130 mg/m2 IV (Day 1) Capecitabine: 1000 mg/m2 Oral (twice daily Days 1 – 14).
- Intervention: Drug: ABT-700 plus Oxaliplatin and Capecitabine
- Cohort A: Experimental
Purpose:
- Background:
- Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen.
- SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells.
- Objectives:
- To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma.
- To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects).
- To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients’ tumors.
- To learn how the body breaks down SS1(dsFV)PE38.
- Eligibility:
- Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy.
- Design:
- Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:
-
- Day 1 – Intravenous (through a vein) infusions of pemetrexed and cisplatin.
- Days 1 and 2 – Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38.
- Days 1, 3 and 5 – Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined.
- Continuing standard treatment with additional cycles of pemetrexed and cisplatin.
- Evaluations during the treatment period:
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- Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
- Questions about medications and side effects.
- Blood and urine tests.
- Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests, pulse oximetry, performance of daily activities and quality-of-life questionnaires.
- Post-treatment evaluations:
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- Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease assessment.
- End-of-study visit for bl…
Purpose:
- Background:
- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.
- Objectives:
- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.
- Eligibility:
- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.
- Design:
-
- Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
- Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
- Participants will have a third imaging study of the cancer about 1 week after the infusions.
- Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients’ symptoms or side effects. This interview can be done in person or by phone….
Purpose: The main purpose of this study is to compare two types of care – standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients’ and caregivers’ quality of life, mood, coping and understanding of their illness.
Primary Objective: To collect detailed clinical information on patients with thoracic malignancies via the electronic medical record and a detailed patient questionnaire, collect blood samples, retrieve paraffin embedded tissue if not collected at Stanford, and perform exploratory molecular analysis of tumor tissues.
Rationale: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more cancer cells.
Purpose: This phase I/II trial is studying the side effects and best dose of gemcitabine hydrochloride when given together with pemetrexed disodium and to see how well they work in treating patients with advanced mycosis fungoides or Sézary syndrome.
