TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
aldesleukin
+ recombinant interferon alfa
+ cisplatin
Neoplasms+9
+ Neoplasms by Histologic Type
+ Neoplasms by Site
Treatment Study
Summary
Study start date: June 1, 1995
Actual date on which the first participant was enrolled.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 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses. Patients are followed every 2 months for 6 months, then every 3 months thereafter. PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 24 locations
Landeskrankenanstalten - Salzburg
Salzburg, AustriaOpen Landeskrankenanstalten - Salzburg in Google MapsHopital Universitaire Erasme
Brussels, BelgiumInstitut Jules Bordet
Brussels (Bruxelles), BelgiumUniversitair Ziekenhuis Antwerpen
Edegem, Belgium