Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
Recombinant Interferon Alfa (IFN-A)
+ Recombinant Interferon Alfa (IFN-A)
+ Aldesleukin (IL-2)
Neoplasms+9
+ Neoplasms by Histologic Type
+ Neoplasms by Site
Treatment Study
Summary
Study start date: November 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas - MD Anderson Cancer Center
Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps