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Brief Title: Nitrocamptothecin in Treating Patients With Metastatic Melanoma
Official Title: Phase II Evaluation of RFS 2000 (9-Nitro-Camptothecin, 9NC) in Metastatic Melanoma
Study ID: NCT00005875
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.
Detailed Description: OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma. OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
SuperGen, Incorporated, Dublin, California, United States
Name: Show-Li Sun, MD
Affiliation: Astex Pharmaceuticals, Inc.
Role: STUDY_CHAIR