Melanoma, Skin Cancer
Conditions
Keywords
stage III melanoma
Brief 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.
Interventions
BIOLOGICALAldesleukin (IL-2)
Infusion for a total of 96 hours on days 1-4
BIOLOGICALRecombinant 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
DRUGCisplatin
IV Days 1-4
DRUGDacarbazine
IVPB on day 1
DRUGVinblastine
IVPB on days 1-4
PROCEDUREAdjuvant 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.
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma | 1 year |
Countries
United States
Outcome results
None listed