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

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Cancer and Leukemia Group B
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003027
First received: November 1, 1999
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: filgrastim
Biological: recombinant interferon alfa
Drug: cisplatin
Drug: dacarbazine
Drug: vinblastine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (complete and partial response) [ Designated as safety issue: No ]
  • Durable complete response rate [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]

Estimated Enrollment: 482
Study Start Date: October 1997
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003027

  Show 94 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Southwest Oncology Group
Cancer and Leukemia Group B
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
  More Information

Additional Information:
Publications:
Atkins MB, Lee S, Flaherty LE: A prospective randomized phase III trial of concurrent biochemotherapy (BCT) with cisplatin, vinblastine, dacarbazine (CVD), IL-2 and interferon alpha-2b (IFN) versus CVD alone in patients with metastatic melanoma (E3695): an ECOG-coordinated intergroup trial. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2847, 2003.

ClinicalTrials.gov Identifier: NCT00003027     History of Changes
Other Study ID Numbers: CDR0000065617, E3695, CLB-509802, SWOG-E3695
Study First Received: November 1, 1999
Last Updated: January 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Cisplatin
Interferon-alpha
Interferons
Vinblastine
Anti-Infective Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014