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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: aldesleukin
* Biological: recombinant interferon alfa
* Drug: cisplatin
* Drug: dacarbazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: recombinant interferon alfa|nan|
|Drug: cisplatin|nan|
|Drug: dacarbazine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma