Kidney Cancer Clinical Trial
Official title:
A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin,
work in different ways to stop tumor cells from dividing so they stop growing or die.
17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking
the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin
works in treating patients with metastatic kidney cancer.
OBJECTIVES:
Primary
- Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients
with metastatic papillary or clear cell renal cell carcinoma.
Secondary
- Determine the safety of this drug in these patients.
- Correlate tumor c-met expression with response in patients treated with this drug.
OUTLINE: This is an open-label study. Patients are stratified according to histology
(papillary vs clear cell).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes on
days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 1 year in the absence of
disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this
study within 6-20 months (clear cell stratum) and 2-5 years (papillary stratum).
;
Masking: Open Label, Primary Purpose: Treatment
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