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

Condition	Treatment or Intervention	Phase
stage III melanoma	Drug: cisplatin  Drug: dacarbazine  Drug: interferon alfa  Drug: interleukin-2  Drug: vinblastine  Procedure: adjuvant therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: cytokine therapy  Procedure: interferon therapy  Procedure: interleukin therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  10 Years   -   70 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000065188; MDA-ID-95196; MDA-DM-95196; NCI-G96-1089
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002882
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08