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Pilot Trial to Determine Toxicity and Antibody Responses with a Vaccine Containing GD2 Lactone and GD3 Lactone in Patients with Disease-Free Stage III or IV Melanoma
[Protocol 06-086]
- Full Title :
- PILOT TRIAL TO DETERMINE THE ANTIBODY RESPONSES TO 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
- Purpose :
Vaccines contain substances that help the body make antibodies, which help protect against a variety of harmful substances. GD2 and GD3 gangliosides are substances found on the surfaces of most melanoma cells and occasionally on some normal cells. Large quantities of antibodies called monoclonal antibodies have been prepared in the laboratory against GD2 and GD3 and have been given to patients with metastatic melanoma. In about 10 percent of cases, this treatment 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 may be as effective as monoclonal antibodies. In this study, researchers want to see if a vaccine containing modified forms of GD2 and GD3 (called lactones) can raise the level of antibodies against GD2 and GD3 in patients whose stage III or IV melanoma has been surgically removed but has a high chance of returning.
Patients' antibody responses to the vaccine as well as any side effects will be monitored.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of stage III or IV cutaneous melanoma that has been surgically removed between 2 weeks and 1 year previously.
- At least 4 weeks must pass since completion of any prior chemotherapy, radiation therapy, or systemic immunotherapy and receipt of the vaccine.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Ruth Roman, RN, at 212-638-8070.
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