Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery

Inclusion Criteria

• Patients must have HLA-A2 status known prior to randomization; typing may be obtained through a local laboratory facility or through a reference lab utilized by the initiating institution; if typing is not available through these means, it may be obtained from the University of Pittsburgh
• All patients must have disease completely resected with one of the following in order to be eligible:
• Completely resected disease
• Any locoregional recurrence after prior adjuvant interferon or failure on S008
• Any local recurrence of disease after adequate surgical excision of the original primary
• Mucosal melanoma
• Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary)
• The following groups of patients may be entered onto this trial only if they are ineligible for S0008 or are, in the opinion of the managing physician, medically unfit to receive standard high-dose interferon:
• Any clinically evident satellite or in-transit disease
• Stage II disease with gross extracapsular extension
• Recurrence in a previously resected nodal basin
• Four or more involved lymph nodes or matted lymph nodes
• Ulcerated primary melanoma and any involved lymph nodes
• NOTE: Patients who are eligible for S0008 will be strongly encouraged to participate in that study in preference to this one
• Patients must have been surgically rendered free of disease with negative margins on resected specimens; patients rendered free of disease by non-surgical means are not eligible
• Patients must be randomized within 112 days (16 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, all required surgeries must be accomplished within this 16 week time period
• Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial; one systemic treatment after a prior surgery is allowed, and must have been completed >= 8 weeks prior to randomization; (when chemotherapy and biotherapy are given together as one planned treatment [biochemotherapy], this counts as one regimen); NOTE: Previous radiation therapy, including after the resection, is allowed as long as 30 days elapse between the radiation and initiation of therapy
• Prior treatment with GM-CSF or any peptides used in this protocol, is not allowed
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patients must not have an active infection requiring treatment with parenteral antibiotics
• Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that may interfere with compliance on any of the E4697 treatment regimens
• Patients must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol
• Patients must be able to self-administer or arrange for administration of subcutaneous injections
• Patients who have other current malignancies are not eligible
• Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible; patients who meet this criteria must be disease-free at time of randomization
• Patients with prior history of basal or squamous skin cancer are eligible; patients who meet this criteria must be disease-free at time of randomization
• Patients who have had multiple primary melanomas are eligible
• Patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization
• Patients must not have autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone), continuous use of t