RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma.
OBJECTIVES: Primary * Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma. * Determine the progression-free rate in patients treated with this drug. Secondary * Determine the toxicity profile of this drug in these patients. * Determine the duration of response in patients treated with this drug. * Determine the survival of patients treated with this drug. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of treatment, disease response is assessed. Patients with stable or responding disease receive additional courses of treatment. After completion of study treatment, patients are followed at 28 days and then every 3 months thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-18 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Disease stabilization at 6 months
Toxicity profile as measured by NCI CTCAE version 3
Response duration
Survival
Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1
B-RAF and RAS mutation status at baseline
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