PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
Advanced Malignant Mesothelioma
Recurrent Malignant Mesothelioma
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma|
- Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Estimated using the product-limit method of Kaplan and Meier.
- Time to Progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Estimated using the product-limit method of Kaplan and Meier.
- Toxicity Profile as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Toxicity will be monitored on an ongoing basis according to guidelines based on the sequential probability ratio test.
- Apoptosis by TUNEL Assay [ Time Frame: At baseline ] [ Designated as safety issue: No ]Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
- Histone Acetylation by IHC and Western Blotting [ Time Frame: At baseline and at 4 hours after last dose of PXD101 on day 5 ] [ Designated as safety issue: No ]Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
|Study Start Date:||June 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (belinostat)
Patients receive PXD101 IV at 1000 mg/m2 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.
Other Name: PXD101Other: laboratory biomarker analysis
I. Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365053
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Suresh Ramalingam||Beckman Research Institute|