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PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery

2014-08-27 03:43:01 | BioPortfolio

Summary

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.

PURPOSE: 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.

Description

OBJECTIVES:

Primary

- Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101.

Secondary

- 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Mesothelioma

Intervention

belinostat, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis

Location

Tower Cancer Research Foundation
Beverly Hills
California
United States
90211

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:01-0400

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