Trials / Completed
CompletedNCT00365053
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Advanced Malignant Mesothelioma
- Epithelial Mesothelioma
- Recurrent Malignant Mesothelioma
- Sarcomatous Mesothelioma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | belinostat | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2006-08-17
- Last updated
- 2018-06-07
- Results posted
- 2014-12-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00365053. Inclusion in this directory is not an endorsement.