Irofulven in Treating Patients With Stage IV Melanoma

This study has been completed.

First Received: July 5, 2000 Last Updated: July 23, 2008 History of Changes

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005968

Purpose

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	Intervention	Phase
Melanoma (Skin)	Drug: irofulven	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: 6-(Hydroxymethyl)acylfulvene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005968

Locations

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

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Rene Gonzalez, MD

University of Colorado at Denver and Health Sciences Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067951, UCHSC-99468, NCI-T99-0070
Study First Received:	July 5, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00005968 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Radiation-Sensitizing Agents
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Irofulven
Neuroepithelioma

Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Irofulven
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009