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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cisplatin; Dacarbazine; Interferon alpha-2; Interferon-alpha; Interferons; Interleukin-2; Vinblastine

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