17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic 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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Disease stabilization at 6 months [ Designated as safety issue: No ]
- Toxicity profile as measured by NCI CTCAE version 3 [ Designated as safety issue: Yes ]
- Response duration [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1 [ Designated as safety issue: No ]
- B-RAF and RAS mutation status at baseline [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Timothy Eisen||Cambridge University Hospitals NHS Foundation Trust|