Melanoma Clinical Trial
Irofulven in Treating Patients With Stage IV Melanoma
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 irofulven in treating patients who have stage IV melanoma.
Full Description
OBJECTIVES: I. Determine the response rate and duration of response in patients with stage IV malignant melanoma treated with 6-hydroxymethylacylfulvene. II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-5. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 2 receive additional courses. Patients are followed every 3 months for 5 years, and then annually thereafter until death.
PROJECTED ACCRUAL: Approximately 16-35 patients will be accrued for this study within 1 year.
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage IV malignant melanoma No prior chemotherapy OR No more than 1 prior chemotherapy containing regimen Measurable disease Brain metastasis allowed if adequately treated
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from any prior therapy No other concurrent therapy
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There are 5 Locations for this study
Santa Monica California, 90404, United States
Denver Colorado, 80220, United States
Denver Colorado, 80262, United States
Park Ridge Illinois, 60068, United States
Columbia Missouri, 65203, United States
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