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Irofulven in Treating Patients With Stage IV Melanoma

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00005968
Collaborator
National Cancer Institute (NCI) (NIH)
5
Locations
37
Duration (Months)

Study Details

Study Description

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 irofulven in treating patients who have stage IV melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma
Study Start Date :
Nov 1, 1999
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Dec 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Wayne Cancer Institute Santa Monica California United States 90404
    2 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    3 University of Colorado Cancer Center Denver Colorado United States 80262
    4 Lutheran General Hospital Park Ridge Illinois United States 60068
    5 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203

    Sponsors and Collaborators

    • University of Colorado, Denver
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Rene Gonzalez, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT00005968
    Other Study ID Numbers:
    • 99-0468.cc
    • UCHSC-99468
    • NCI-T99-0070
    First Posted:
    Jun 21, 2004
    Last Update Posted:
    May 30, 2013
    Last Verified:
    Dec 1, 2002
    Keywords provided by University of Colorado, Denver
    stage IV melanoma
    Additional relevant MeSH terms:
    Melanoma
    Irofulven

    Study Results

    No Results Posted as of May 30, 2013