Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase 1 Study of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG, NSC #707545) in Patients With Solid Tumors.
This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES:
I. Determine the toxic effects and maximum tolerated dose of
17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or
unresectable solid tumors.
SECONDARY OBJECTIVES:
II. Determine the effects of this drug on the expression of Hsp90 client proteins in normal
and tumor tissue samples from these patients.
OUTLINE: This is a dose-escalation study.
Patients receive alvespimycin hydrochloride IV over 1 hour on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-2 patients receive accelerated escalating doses of alvespimycin hydrochloride
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 alvespimycin
hydrochloride 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. Once the MTD is
determined, 10 additional patients are treated at that dose.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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