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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334789 |
RATIONALE: PXD101 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid tumor cells to look more like normal cells, and to grow and spread more slowly. Giving PXD101 together with isotretinoin may be an effective treatment for metastatic or unresectable solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of PXD101 when given together with isotretinoin in treating patients with metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: belinostat Drug: isotretinoin Procedure: biopsy Procedure: gene expression analysis Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of PXD101 in Combination With 13-Cis-Retinoic Acid in Advanced Solid Tumor Malignancies |
Estimated Enrollment: | 36 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of PXD101.
Patients receive PXD101 IV over 30 minutes on days 1-5 and oral isotretinoin once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PXD101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of therapy.
Once the MTD is determined, an expanded cohort of 10 patients are enrolled and treated at the MTD. These patients also undergo blood collection periodically during treatment for pharmacokinetic studies.
All patients undergo blood collection, buccal scrapings, and tumor biopsies periodically for biomarker, pharmacodynamic, gene expression, and laboratory studies.
After completion of study treatment, patients are followed for ≥ 8 weeks.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor
PATIENT CHARACTERISTICS:
No significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent medication that may cause torsades de pointes, including any of the following:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
Contra Costa Regional Medical Center | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Sharon Hiner, MD 925-370-5114 shiner@hsd.co.contra-costa.ca.us | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 |
Study Chair: | Thehang H. Luu, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000479715, CCC-PHI-53, NCI-7251 |
Study First Received: | June 7, 2006 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00334789 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Isotretinoin Tretinoin |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions |