Ensayos clínicos

DISEASE CHARACTERISTICS:

• Histologically confirmed primary melanoma of cutaneous origin
  • Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
    • Clinically negative regional lymph node pathologic status unknown OR
    • Histologically negative regional lymph nodes
  • Stage III (T4 N0 M0)
    • Greater than 4.0 mm Breslow depth OR
  • Stage III (T1-4 N1)
    • One lymph node positive microscopically
• Patients must meet at least 1 of the following criteria:
  • T_2b N_0 - primary melanoma 1.01-2.0 mm with ulceration, node negative
  • T_3a-b N_0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
  • T_4a-b N_0 - primary melanoma > 4.0 mm with or without ulceration, node negative
  • T_1-a N_1a-2a (microscopic) - primary melanoma of any thickness with microscopically positive lymph node (any number)
• Patients with a positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
• Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in this study within 84 days of wide excision
• Must have undergone an adequate wide excision of the primary lesion
• No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
• No clinically palpable lymphadenopathy

PATIENT CHARACTERISTICS:

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: Not specified
• Hematopoietic:
  • WBC at least 3,000/mm^3
  • Platelet count at least 125,000/mm^3
  • Hematocrit at least 30%
• Hepatic:
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST, LDH, and alkaline phosphatase no greater than 2 times ULN
  • If lactate dehydrogenase or alkaline phosphatase is above normal, a contrast-enhanced CT scan or MRI of the liver is required to document the absence of tumor
• Renal:
  • BUN no greater than 33 mg/dL OR
  • Creatinine no greater than 1.8 mg/dL
• Cardiovascular:
  • No history of active ischemic heart disease
  • No cerebrovascular disease
  • No congestive heart failure (New York Heart Association class III or IV heart disease)
• Other:
  • No other history of invasive melanoma
  • No autoimmune disorders or conditions of immunosuppression
  • No other concurrent or prior malignancies within the past 5 years except:
    • Cancer in situ
    • Lobular carcinoma in situ of the breast
    • Carcinoma in situ of the cervix
    • Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
    • Basal or squamous cell skin cancer
  • No evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
  • No other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

• Biologic therapy: No prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma
• Chemotherapy: No prior or concurrent chemotherapy
• Endocrine therapy: No concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers
• Radiotherapy: No prior or concurrent radiotherapy
• Surgery: See Disease Characteristics
• Other: No other concurrent immunosuppressive medications