Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
Condition: Melanoma; Skin Cancer
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): Aldesleukin (IL-2); Recombinant Interferon Alfa (IFN-A); Cisplatin; Dacarbazine; Vinblastine; Adjuvant Therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Procedure
Intervention description(s): Infusion for a total of 96 hours on days 1-4; 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; IV Days 1-4; IVPB on day 1; IVPB on days 1-4; Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.
Other intervention name(s): IL-2; Interleukin-2; Proleukin; interferon alfa-2b; IFN-A; CDDP; Platinol; Platinol-AQ; DTIC; Velban
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Aldesleukin; Cisplatin; Interleukin-2; Dacarbazine; Vinblastine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III melanoma