- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005968
Irofulven in Treating Patients With Stage IV Melanoma
A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma
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.
Study Overview
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Santa Monica, California, United States, 90404
- John Wayne Cancer Institute
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Colorado
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
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Illinois
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Park Ridge, Illinois, United States, 60068
- Lutheran General Hospital
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Rene Gonzalez, MD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Irofulven
Other Study ID Numbers
- 99-0468.cc
- UCHSC-99468
- NCI-T99-0070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma (Skin)
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Roswell Park Cancer InstituteCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IIIA Skin MelanomaUnited States, Australia
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaCompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IV Uveal Melanoma | Stage IIIA Skin Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal Melanoma | Recurrent Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed
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