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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Given IV
Correlative studies
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Maximum tolerated dose of alvespimycin hydrochloride
Time frame: 21 days
Toxicity graded using the NCI CTCAE version 3.0
Time frame: Up to 4 weeks
Recommended phase II dose (RP2D) of alvespimycin hydrochloride for future studies determined by toxicity assessments
Time frame: 21 days
Pharmacokinetics of alvespimycin hydrochloride in blood, urine, and tumor tissue
Analyzed by both non-compartmental and compartmental methods.
Time frame: 21 days
Tumor response assessed by tumor measurements
Time frame: Up to 4 weeks
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