Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma

Inclusion Criteria:

Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that

They have received all injections with evidence of an immune response
They have not experienced recurrence of the melanoma
Not more than twelve months have elapsed since the final injection on either protocol
They experienced no grade 3 or 4 toxicity attributed to the prior vaccine regimen
Serum creatinine of 2.0 mg/dl or less
Total bilirubin of 2.0 mg/dl or less
SGOT/SGPT of 2.5 X institutional norm or less
Total WBC of 3,000 or more
At least 1500 granulocytes
Hemoglobin of 9.0 gm/dl or more
Platelet count of 100,000 per cu mm. or more
ECOG performance status of 0 or 1
Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it
Ability to read, understand and willingness to sign an IRB-approved informed consent
Patients who have had another malignancy but with no evidence of disease for greater than 5 years from accrual to the current trial will be eligible if it is felt they are likely to be cured; patients with squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have been treated with curative intent can be accrued to this trial 30 days after treatment

Exclusion Criteria:

Who have undergone any other systemic therapy for their melanoma, including radiation therapy since completion of 10M-01-1 or 10M-00-4
Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems
Who require systemic, ocular or inhaled corticosteroids
Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase, MART-1 or gp100 is felt to present a risk to the fetus or a breast feeding infant; effective birth control for men and women is required during and for four months after the study is finished
Who are known to be positive for hepatitis BsAg, hepatitis C antibody or HIV antibody; since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of melanoma peptides might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated on this trial
Who have had a known allergic reaction to GM-CSF, Montanide ISA 51 (IFA) or any of the peptides included in this protocol
Who have a prior history of uveitis or autoimmune inflammatory eye disease, immune hemolytic anemia or other active autoimmune disease