S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence
• * No distant metastases
• * No melanoma of ocular, mucosal, or other non-cutaneous origin
• One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:
• * Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt)
• * Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass
• * No non-ulcerated or unknown primary tumor and a single micrometastatic lymph node
• * Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes
• * Any satellite/in transit metastasis with or without lymph node involvement
• Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy
• Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site
• Patients must be disease free at time of enrollment based on the following surgical criteria:
• * Patients at initial presentation of melanoma must undergo adequate wide excision of primary lesion
• * Patients with previously diagnosed melanoma must have all disease resected with pathologically negative margins and no disease at primary site or second resection of primary
• * Full lymphadenectomy required of all patients including those with positive sentinel nodes or positive satellite/in-transit metastasis
• No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy
• Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Zubrod 0-1
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2 times ULN
• LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires a contrast-enhanced CT scan or MRI of liver)
• No known recent hepatitis positivity by PCR
• Renal:
• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 75 mL/min
• Cardiovascular:
• No congestive heart failure
• No coronary artery disease
• No serious cardiac arrhythmia
• No prior myocardial infarction
• Normal cardiac stress test required if any of the following are present:
• * Over age 50
• * Abnormal EKG
• * History of cardiac disease
• Pulmonary:
• No symptomatic pulmonary disease
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No autoimmune disorders or conditions of immunosuppression
• No other prior malignancy within the past 5 years except the following:
• * Adequately treated basal cell or squamous cell skin cancer
• * Carcinoma in situ of the cervix
• * Adequately treated stage I or II cancer in remission
• HIV negative
• No known AIDS or HIV-1 associated complex
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior immunotherapy, including interferon, interleukin, levamisole, or other biologic response modifiers
• No other concurrent biologic therapy
• Chemotherapy:
• No prior chemotherapy (including infusion or perfusion therapy)
• No other concurrent chemotherapy
• Endocrine therapy:
• No concurrent systemic corticosteroids or topical steroid creams
• Concurrent steroid antihistamines allowed if no alternative
• No concurrent hormonal therapy
• Radiotherapy:
• No prior radiotherapy
• * Prior postlumpectomy radiotherapy for breast cancer allowed
• No concurrent radiotherapy
• Surgery:
• See Disease Characteristics
• No concurrent surgery
• Other:
• No concurrent anti-hypertensive medications (arm II only)
• No concurrent immunosuppressive agents
• No other concurrent anticancer therapy
• Antihistamines allowed if no alternative medication suitable