Melanoma (Skin) Clinical Trial
Official title:
A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma
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.
;
Masking: Open Label, Primary Purpose: Treatment
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