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 6-hydroxymethylacylfulvene in treating patients who have stage IV melanoma.

Condition	Treatment or Intervention	Phase
Stage IV Melanoma	Drug: -hydroxymethylacylfulvene	Phase II

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• See Disease Characteristics
• Recovered from any prior therapy
• No other concurrent therapy

--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

California
      John Wayne Cancer Institute, Santa Monica,  California,  90404,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States
Illinois
      Lutheran General Hospital, Park Ridge,  Illinois,  60068,  United States
Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States

Study chairs or principal investigators

Rene Gonzalez,  Study Chair,  University of Colorado Cancer Center   

Study ID Numbers:  CDR0000067951; UCHSC-99468; NCI-T99-0070
Record last reviewed:  June 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005968
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20