Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

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.

Eligibility: 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

Relevance to patient case: not relevant