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| Sponsor: | California Cancer Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00365053 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: belinostat Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of PXD 101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma |
| Estimated Enrollment: | 37 |
| Study Start Date: | June 2006 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes:
Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| Contra Costa Regional Medical Center | |
| Martinez, California, United States, 94553 | |
| Tower Cancer Research Foundation | |
| Beverly Hills, California, United States, 90211 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Study Chair: | Suresh Ramalingam, MD | Emory University |
More Information
| Responsible Party: | University of California Davis Cancer Center ( David R. Gandara ) |
| Study ID Numbers: | CDR0000489194, CCC-PHII-67, NCI-7255 |
| Study First Received: | August 16, 2006 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00365053 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
epithelial mesothelioma sarcomatous mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Mesothelial |
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |