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RATIONALE: 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.
- Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101.
- Determine the overall survival and time to progression in these patients.
- Assess the toxicities associated with this drug in these patients.
- Perform molecular correlative studies on tumor tissue (optional) and peripheral blood (required) and identify potential predictive markers for response.
OUTLINE: This is a multicenter study.
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.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
belinostat, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
Tower Cancer Research Foundation
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:43:01-0400
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