PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00365053|
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : December 29, 2014
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma||Drug: belinostat Other: laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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: PXD101
Other: laboratory biomarker analysis
- Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [ Time Frame: Up to 3 years ]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 ]Estimated using the product-limit method of Kaplan and Meier.
- Progression-free Survival [ Time Frame: Up to 3 years ]Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Toxicity Profile [ Time Frame: Up to 3 years ]Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- Apoptosis by TUNEL Assay [ Time Frame: At baseline ]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 ]Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365053
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Suresh Ramalingam||City of Hope Medical Center|