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A Phase III Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy
[Protocol 05-095]
- Full Title :
- A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL SUBEROYLANILIDE HYDROXAMIC ACID (L-001079038)IN PATIENTS WITH ADVANCED MALIGNANT PLEURAL MESOTHELIOMA PREVIOUSLY TREATED WITH SYSTEMIC CHEMOTHERAPY
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of a new investigational drug called L-001079038 (also known as suberoylanilide hydroxamic acid or vorinostat) in patients with mesothelioma whose cancer has grown after prior chemotherapy with pemetrexed and either cisplatin or carboplatin. L-001079038 targets proteins that regulate which genes will be turned on or off in cancer cells.
Patients will be randomly assigned to receive L-001079038 or a placebo. Researchers will determine if treatment with L-001079038 improves survival, shrinks mesothelioma tumors, increases the time it takes for mesothelioma tumors to grow, reduces symptoms, and improves breathing function.
Investigators will also collect a small sample of blood from some patients for analysis to determine the effect of L-00107038 treatment on a patient's genes.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of pleural mesothelioma that has returned or continued to grow following standard treatment which included pemetrexed and either cisplatin or carboplatin.
- Patients may not have had more than two prior regimens of chemotherapy. The most recent regimen must have contained pemetrexed. At least 4 weeks must have passed between prior chemotherapy or radiation therapy and entry into the study, and patients must have recovered from all side effects.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Lee M. Krug at 212-639-8420.
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