Melanoma Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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