Vaccines contain substances that help us make antibodies. Different antibodies help protect
us against a variety of harmful things. GD2 and GD3 gangliosides are substances found on the
surface of most melanoma cells. They are also occasionally found on some normal cells. Large
quantities of antibodies called monoclonal antibodies have been prepared in the laboratory
against GD2 and GD3 and given to patients with metastatic melanoma. In about 10% of cases
this has resulted in clinically relevant regression of melanomas. These monoclonal
antibodies are not currently available or used in the clinic but studies in the laboratory
indicate that vaccines against GD2 and GD3 can be as effective as monoclonal antibodies.
In this trial we wish to raise the level of antibodies in your blood against GD2 and GD3. We
will vaccinate you with the modified forms of GD2 called GD2 lactone and GD3 called GD3
lactone (GD3L), all attached to the antibody booster KLH, and mixed with the immune booster
(immunologic adjuvant) QS-DG. While over a thousand patients have received vaccines with
QS-21, the QS-DG used here is synthesized for the first time at MSKCC and is referred to as
QS-DG rather than QS-21 which is purified from tree bark. QS-21 and QS-DG are, to the best
of our knowledge chemically identical. It is unknown if using this bivalent vaccine will
raise the level of antibodies in your blood to either ganglioside. It is unknown if raising
the level of antibodies in your blood will lower your risk of relapse. This study will check
your blood for production of antibodies, and check you for side effects.
- 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.