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A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma

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

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Rene Gonzalez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver


United States: Federal Government

Study ID:



Start Date:

November 1999

Completion Date:

December 2002

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma



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