Vaccine Therapy and/or Sargramostim in Treating Patients With Locally Advanced or Metastatic Melanoma

DISEASE CHARACTERISTICS:

• Histologically proven completely resected melanoma including one of the following:

  • Any locoregional recurrence after prior adjuvant interferon or failure on SWOG-0008
  • Any local recurrence after adequate surgical excision of the original primary
  • Mucosal melanoma

  • Stage IV disease including:

    • Cutaneous melanoma
    • Ocular melanoma
    • Mucosal melanoma
• Multiple primary lesions allowed

• If ineligible for SWOG-0008 or are determined by managing physician to be medically unfit to receive standard high-dose interferon, patients with one of the following may be eligible:

  • Any clinically evident satellite or intransit disease
  • Stage III disease with gross extracapsular extension
  • Recurrence in previously resected nodal basin
  • Four or more involved lymph nodes or matted lymph nodes
  • Ulcerated primary melanoma and any involved lymph nodes
• Known HLA-A2 status

• Rendered free of disease with negative margins by surgical means only

  • Ineligible if rendered free of disease by nonsurgical means

• Must be randomized within 16 weeks of surgical resection

  • If more than one surgical procedure is required to render the patient disease free, all required surgeries must be completed within this 16-week time period
• Patients with bone pain must have a negative bone scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• SGOT no greater than 2 times upper limit of normal (ULN)
• Bilirubin no greater than 2 times ULN
• LDH normal
• Alkaline phosphatase no greater than ULN (1.25 times ULN if negative CT scan or MRI of liver and negative bone scan or negative PET scan)

Renal:

• Creatinine no greater than 1.8 mg/dL

Other:

• No active infection requiring treatment with IV antibiotics
• No other significant medical, surgical, or psychiatric condition or requirement for medication or treatment that would preclude study compliance
• No diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function that would preclude study compliance
• Able to self administer or arrange for administration of subcutaneous injections

• No other malignancy within the past 5 years except any of the following curatively treated cancers:

  • Lobular carcinoma in situ of the breast
  • Carcinoma in situ of the cervix
  • Any other in situ cancer
  • Atypical melanocytic hyperplasia
  • Clark's level I melanoma (melanoma in situ)
  • Basal cell or squamous cell skin cancer
• No autoimmune disorder
• No condition of immunosuppression
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 18 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics
• No prior sargramostim (GM-CSF)
• No prior MART-1:27-35 peptide, tyrosinase:368-376, or gp100:209-217 (210M) antigen
• No prior adjuvant biologic therapy after resection(s) that rendered the patient disease-free with negative margins

• One prior systemic regimen after prior surgery allowed if completed at least 8 weeks ago

  • Chemotherapy and biologic therapy administered together as one planned treatment count as one regimen

Chemotherapy:

• See Biologic therapy
• No prior adjuvant chemotherapy after resection(s) that rendered the patient disease-free with negative margins

Endocrine therapy:

• At least 2 weeks since prior systemic corticosteroids, including oral steroids (e.g., prednisone or dexamethasone)
• At least 2 weeks since prior continuous use of topical steroid creams or ointments or any steroid-containing inhalers
• Concurrent replacement doses of steroids for adrenal insufficiency allowed
• No concurrent systemic corticosteroids, including oral steroids (e.g., prednisone or dexamethasone)
• No concurrent continuous use of topical steroid creams or ointments or any steroid-containing inhalers

Radiotherapy:

• At least 30 days since prior radiotherapy, including after the resection

Surgery:

• See Disease Characteristics
• See Biologic therapy
• See Chemotherapy
• See Radiotherapy

Other:

• No prior adjuvant limb perfusion after resection(s) that rendered the patient disease-free with negative margins
• No concurrent IV antibiotics