A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
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
year.
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:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Rene Gonzalez, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Colorado, Denver
Authority:
United States: Federal Government
Study ID:
99-0468.cc
NCT ID:
NCT00005968
Start Date:
November 1999
Completion Date:
December 2002
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| 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 |
