Trials / Completed
CompletedNCT00104897
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma
A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Cancer Research UK · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tanespimycin |
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2005-03-04
- Last updated
- 2013-06-26
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00104897. Inclusion in this directory is not an endorsement.