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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103220 |
RATIONALE: Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: SJG-136 |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | SJG136 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study With SJG-136 (NSC#694501) in Patients With an Advanced Solid Tumor |
Estimated Enrollment: | 36 |
Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 IV over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SJG-136 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. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 3-36 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 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
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Naiyer Rizvi, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000409581, MSKCC-04076, NCI-6818 |
First Received: | February 7, 2005 |
Last Updated: | June 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00103220 |
Health Authority: | United States: Food and Drug Administration |
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