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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084812 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: safingol |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | An Open-Labeled, Non-Randomized Phase I Study of Safingol Administered With Cisplatin in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 52 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, non-randomized, dose-escalation study of safingol.
Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration.
Cohorts of 3-6 patients receive escalating doses of safingol 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. Once the MTD is determined, 10 additional patients are treated at that dose level.
PROJECTED ACCRUAL: A total of 3-52 patients will be accrued for this study within 1-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent vitamins, antioxidants, herbal preparations, or supplements
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Gary K. Schwartz, MD 212-639-8324 |
Principal Investigator: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Archie N. Tse, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000365622, MSKCC-04002 |
Study First Received: | June 10, 2004 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00084812 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Cisplatin Safingol |
Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions |