Combination Chemotherapy, Interferon Alfa, and Interleukin-2 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. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Aldesleukin; Dacarbazine; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma that is metastatic and unresectable

• Measurable, progressive disease (by physical exam and/or noninvasive imaging)

• No prior irradiation of indicator lesions

• No CNS metastases (confirmed by CT or MRI)

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Greater than 3 months

Hematopoietic:

• WBC at least 2,500/mm^3

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

Hepatic:

• No serious hepatic disease

Renal:

• Creatinine no greater than 1.65 mg/dL

• No serious renal disease

Cardiovascular:

• No serious cardiac disease

Pulmonary:

• No serious pulmonary disease

Other:

• No organ allograft

• No autoimmune disease

• No uncontrolled infection

• No active peptic ulcer

• No hyper or hypothyroidism

• No requirement for corticosteroids

• No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy with interleukin-2

• No prior interferon alfa in combination with cisplatin or dacarbazine

Chemotherapy:

• No prior chemotherapy with cisplatin in combination with dacarbazine

• More than 3 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed

Surgery:

• Not specified