A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma

CDR0000065617

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.

1997-11-13

2007-07-01

Early phase I

482

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 482, 'type': 'ESTIMATED'}}

2023-06-22