Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Apr 10, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
* Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days...

Gender

ALL

Eligibility 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

Trial Officials