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

June 20, 2023 updated by: Eastern Cooperative Oncology Group

A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

482

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Greater Phoenix
      • Phoenix, Arizona, United States, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, United States, 91010-3000
        • Cancer Center and Beckman Research Institute, City of Hope
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, United States, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • San Francisco, California, United States, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, United States, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, United States, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813-2424
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7353
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71130
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Jamaica Plain, Massachusetts, United States, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
      • Ann Arbor, Michigan, United States, 48109-0912
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Southfield, Michigan, United States, 48075-9975
        • Providence Hospital - Southfield
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
    • Mississippi
      • Biloxi, Mississippi, United States, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
      • Keesler Air Force Base, Mississippi, United States, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Health Sciences Center
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Albany, New York, United States, 12208
        • Veterans Affairs Medical Center - Albany
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, United States, 45267-0501
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Kettering, Ohio, United States, 45429
        • CCOP - Dayton
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, United States, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Program
      • Portland, Oregon, United States, 97239
        • OHSU Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Dallas, Texas, United States, 75235-8852
        • Simmons Cancer Center - Dallas
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • San Antonio, Texas, United States, 78284
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • San Antonio, Texas, United States, 78284-7845
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest
      • Tacoma, Washington, United States, 98431-5048
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Response duration
Response rate (complete and partial response)
Durable complete response rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)
Cancer and Leukemia Group B
SWOG Cancer Research Network

Investigators

  • Study Chair: Michael B. Atkins, MD, Tufts Medical Center
  • Study Chair: Lawrence E. Flaherty, MD, Barbara Ann Karmanos Cancer Institute
  • Study Chair: David M. Gustin, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 1997

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065617
  • E3695
  • CLB-509802
  • SWOG-E3695

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.

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