S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

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