Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors
This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of
17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or
unresectable solid tumors or lymphomas.
II. Determine the safety and toxicity of this drug in these patients. III. Determine the
pharmacokinetics and pharmacodynamics of this drug in these patients.
IV. Determine the recommended phase II dose of this drug for future studies.
SECONDARY OBJECTIVES:
I. Determine tumor response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6
hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of
17-DMAG until at least 1 of 2 patients experience dose-limiting toxicity (DLT). Cohorts are
then expanded to 3-6 patients who receive escalating doses (in a standard manner) of 17-DMAG
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 DLT.
Patients are followed at 4 weeks.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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