Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they
stop growing or die. This phase I trial is studying the side effects and best dose of
17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial
cancer, malignant lymphoma, or sarcoma
I. Determine the dose-limiting toxicity and maximum tolerated dose of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial
cancer, malignant lymphoma, or sarcoma.
II. Determine the significant toxic effects associated with this drug in these patients.
III. Determine the response in patients treated with this drug. IV. Determine the
pharmacokinetics of 17-AAG and 17AG in these patients.
OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2
Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2
hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity.
Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses
repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
In both schedules, cohorts of 3-6 patients receive escalating doses of 17-AAG until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients receive
treatment at the MTD.
PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.
- Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma
for which no standard curative therapy exists
- Brain metastases allowed after definitive radiotherapy
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times normal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for at least 1 week before, during,
and for at least 2 weeks after study completion
- No active infection
- No other serious concurrent condition
- No prior allergic reaction to egg products
- At least 4 weeks since prior biologic therapy (regional or systemic)
- At least 4 weeks since prior chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy