Pilot Trials With a KLH Conjugated Bivalent GangliosideVaccine Mixed With Immunological Adjuvants QS-DG or OPT-821in Patients With Disease Free AJCC Stage III or IV
- 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
- 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
- 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.