Determine Toxicity and Antibody Responses With a KLH Conjugated Bivalent Vaccine Containing GD2 Lactone, GD3 Lactone With Immunological Adjuvant QS-DG or OPT-821 in Patients With Disease Free AJCC Stage III or IV Cutaneous Melanoma

This is an interventional treatment trial for Melanoma focused on measuring melanoma, resected local, systemic metastasis Read More

Inclusion Criteria:

• Patients ≥18 with AJCC stage III or IV melanoma two weeks to one year after becoming clinically free of disease will be eligible.
• For all patients' pathology slides must be reviewed by the Memorial Hospital Department of Pathology to confirm diagnosis of cutaneous melanoma.
• All patients must have a Karnofsky performance status of ≥80.
• Patients may have received previous radiation, chemotherapy or systemic immunotherapy (completed at least 4 weeks prior to vaccination).
• A CBC must be performed within 2 weeks prior to vaccination with the WBC > or equal to 3.0 cells/mm3, Platelets >100,000/mm3,
• A screening profile must be performed within 2 weeks prior to vaccination with the total bilirubin ≤ 2.0, and other LFTs within normal limits for patient's age.
• Chest, abdomen and pelvic CT or MRI must be performed within 4 weeks of the initiation of treatment showing no evidence of disease.
• Women of child bearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment.

Exclusion Criteria:

• Patients previously treated with KLH or ganglioside containing vaccines, or monoclonal antibodies against gangliosides are not eligible.
• Women must not be pregnant (negative βHCG within 2 weeks of vaccination if of childbearing potential).
• Patients with other active cancers within the past 2 years, (excluding basal cell, squamous carcinomas of the skin or cervical carcinoma-in-situ) are not eligible.
• Any medical condition which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to them is grounds for exclusion, at the discretion of the Principal Investigator.
• Patients requiring anti-inflammatory medications such a steroids, NSAIDS or full dose aspirin are not eligible.
• There must be no evidence of metastatic disease at the time of the first vaccine. However, patients who develop new metastases during treatment may continue on treatment as long as no systemic treatment is indicated and any local treatment such as surgical resection or radiation would not cause a delay in vaccination or two weeks or more.