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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: Cancer and Leukemia Group B; National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Aldesleukin; Cisplatin; Dacarbazine; Interferon-alpha; Interferons; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed surgically incurable metastatic malignant melanoma

• Measurable disease

• No active brain metastases or edema

• No leptomeningeal disease

• No ocular melanoma

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT less than 3 times the upper limit of normal unless due to liver metastases

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance at least 75 mL/min

Cardiovascular:

• No congestive heart failure

• No symptoms of coronary artery disease

• No serious cardiac arrhythmias

• No prior myocardial infarction on EKG

• Normal cardiac stress test required for the following:

• Over 50 years of age

• Abnormal EKG

• Prior history of cardiac disease

Pulmonary:

• No symptomatic pulmonary disease

• FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No significant infection

• HIV negative

• No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No organ allografts

• No significant disease other than malignancy

• No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interleukin-2 therapy for metastatic disease

• At least 4 weeks since prior vaccine therapy

• At least 4 weeks since prior adjuvant immunotherapy

Chemotherapy:

• No prior chemotherapy for disease

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiation therapy to measurable disease site unless disease is clearly progressive

• At least 4 weeks since prior radiation therapy for local control or palliation and recovered

Surgery:

• Recovered from prior surgery

Other:

• No prior systemic therapy for metastatic disease

• At least 3 months since definitive therapy for brain metastases