Melanoma Clinical Trial

Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.

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Full Description

OBJECTIVES:

Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b.
Determine the toxic effects of these regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.

Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine.
Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16.

Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed surgically incurable metastatic malignant melanoma
Measurable disease
No active brain metastases or edema
No leptomeningeal disease
No ocular melanoma

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic:

Bilirubin no greater than 1.5 mg/dL
SGOT less than 3 times the upper limit of normal unless due to liver metastases

Renal:

Creatinine less than 1.5 mg/dL OR
Creatinine clearance at least 75 mL/min

Cardiovascular:

No congestive heart failure
No symptoms of coronary artery disease
No serious cardiac arrhythmias
No prior myocardial infarction on EKG

Normal cardiac stress test required for the following:

Over 50 years of age
Abnormal EKG
Prior history of cardiac disease

Pulmonary:

No symptomatic pulmonary disease
FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No significant infection
HIV negative
No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No organ allografts
No significant disease other than malignancy
No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior interleukin-2 therapy for metastatic disease
At least 4 weeks since prior vaccine therapy
At least 4 weeks since prior adjuvant immunotherapy

Chemotherapy:

No prior chemotherapy for disease

Endocrine therapy:

No concurrent corticosteroids

Radiotherapy:

No prior radiation therapy to measurable disease site unless disease is clearly progressive
At least 4 weeks since prior radiation therapy for local control or palliation and recovered

Surgery:

Recovered from prior surgery

Other:

No prior systemic therapy for metastatic disease
At least 3 months since definitive therapy for brain metastases

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT00003027

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 86 Locations for this study

See Locations Near You

MBCCOP - Gulf Coast
Mobile Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock Arkansas, 72205, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles California, 90073, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94143, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
University of Colorado Cancer Center
Denver Colorado, 80010, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40502, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71130, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor Michigan, 48105, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Providence Hospital - Southfield
Southfield Michigan, 48075, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Biloxi
Biloxi Mississippi, 39531, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base Mississippi, 39534, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Missouri, 64128, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
St. Louis University Health Sciences Center
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Kettering Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Columbia River Program
Portland Oregon, 97225, United States
OHSU Cancer Institute
Portland Oregon, 97239, United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina, 29401, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Veterans Affairs Medical Center - Houston
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT00003027

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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