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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00002882
First received: November 1, 1999
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Melanoma
Skin Cancer
Biological: Aldesleukin (IL-2)
Biological: Recombinant Interferon Alfa (IFN-A)
Drug: Cisplatin
Drug: Dacarbazine
Drug: Vinblastine
Procedure: Adjuvant Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: November 1995
Study Completion Date: April 2006
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Recombinant Interferon Alfa (IFN-A)

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.
Biological: Recombinant Interferon Alfa (IFN-A)

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.
Biological: Aldesleukin (IL-2)
Infusion for a total of 96 hours on days 1-4
Other Names:
  • IL-2
  • Interleukin-2
  • Proleukin
Biological: Recombinant Interferon Alfa (IFN-A)

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
Drug: Cisplatin
IV Days 1-4
Other Names:
  • CDDP
  • Platinol
  • Platinol-AQ
Drug: Dacarbazine
IVPB on day 1
Other Names:
  • dacarbazine
  • DTIC
Drug: Vinblastine
IVPB on days 1-4
Other Name: Velban
Procedure: Adjuvant Therapy
Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002882

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Agop Y. Bedikian, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002882     History of Changes
Other Study ID Numbers: ID95-196, P30CA016672, MDA-ID-95196, MDA-DM-95196, NCI-G96-1089, CDR0000065188
Study First Received: November 1, 1999
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
stage III melanoma

Additional relevant MeSH terms:
Skin Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Aldesleukin
Reaferon
Cisplatin
Dacarbazine
Interleukin-2
Vinblastine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014