Recurrent Malignant Mesothelioma Clinical Trial
Official title:
Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma
This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 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.
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with unresectable malignant pleural
mesothelioma (MPM) treated with PXD101.
SECONDARY OBJECTIVES:
I. Determine the overall survival and time to progression in these patients. II. Assess the
toxicities associated with this drug in these patients. III. Perform molecular correlative
studies on tumor tissue (optional) and peripheral blood (required) and identify potential
predictive markers for response.
OUTLINE:
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection during course 1 of treatment for biomarker correlative
studies. Fetal hemoglobin (hemoglobin F) levels are measured via reverse
transcriptase-polymerase chain reaction as a potential predictive marker for response.
After completion of study treatment, patients are followed periodically.
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