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

December 12, 2011 updated by: M.D. Anderson Cancer Center

Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.

Study Overview

Detailed Description

OBJECTIVES:

  • Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b (IFN-A) administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected.
  • Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A, and IL-2 and their effect on the quality of life.
  • Determine the prognostic value of detection of melanoma cells in the peripheral blood using RT/PCR for tyrosinase mRNA.

OUTLINE: This is a randomized study. All patients are stratified according to prognostic factors.

Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy.

Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules.

  • Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
  • Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks. Adjuvant biochemotherapy begins immediately after registration on the study. Cisplatin is given IV on days 1-4; vinblastine is given IVPB on days 1-4; dacarbazine (DTIC) is given IVPB on day 1; IFN-A is given subcutaneously on days 1-5; IL-2 is given by continuous infusion for a total of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4 courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.

Study Type

Interventional

Enrollment (Actual)

140

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

    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer 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

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically diagnosed malignant melanoma with regional lymph node metastases
  • Undergone complete lymph node dissection and free of any residual tumor
  • No greater than 90 days from diagnosis of regional lymph nodes metastases
  • No distant or resected in-transit metastases

PATIENT CHARACTERISTICS:

Age:

  • 10 to 66
  • 66 to 70 if in excellent physical condition

Performance status:

  • 0-2

Life expectancy:

  • At least 12 months

Hematopoietic:

  • Hemoglobin greater than 10 g/dL
  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.2 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • No serious intercurrent illness that would compromise tolerance of therapy and long term survival
  • Must be able to participate in follow up for minimum of 5 years
  • No second malignancy except:

    • In situ cervical cancer
    • Basal or squamous skin cancer
  • Must be able to physically and emotionally tolerate biochemotherapy
  • No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy with interferon or IL-2
  • No concurrent immunomodulators

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • Prior adjuvant local radiotherapy allowed for head and neck

Surgery:

  • No greater than 8 weeks after definitive surgery for lymph node metastases

Other:

  • No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors

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
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IFN-A Therapy Schedule A
Schedule A: IV Interferon alfa-2b (IFN-A) induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

Other Names:
  • interferon alfa-2b
  • IFN-A
Experimental: IFN-A Therapy Schedule B
Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

Other Names:
  • interferon alfa-2b
  • IFN-A
Experimental: Adjuvant Biochemotherapy
Cisplatin IV Days 1-4; Vinblastine IVPB Days 1-4; Dacarbazine (DTIC) IVPB on Day 1; IFN-A is given subcutaneously on days 1-5; IL-2 continuous infusion for 96 hours on Days 1-4. Each course repeated every 21 days for 4 courses.

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

Other Names:
  • interferon alfa-2b
  • IFN-A
Infusion for a total of 96 hours on days 1-4
Other Names:
  • Proleukin
  • IL-2
  • Interleukin-2
IV Days 1-4
Other Names:
  • CDDP
  • Platinol
  • Platinol-AQ
IVPB on day 1
Other Names:
  • DTIC
IVPB on days 1-4
Other Names:
  • Velban
Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Investigators

  • Study Chair: Agop Y. Bedikian, MD, M.D. Anderson Cancer Center

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.

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

November 1, 1995

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

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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