The objective of this research is to evaluate the safety and biological activity of a polyvalent human melanoma antigen vaccine. The innovative aspect of the vaccine is that it contains a mixture of melanoma to maximize induction of an immune response to surface antigens expressed on the patient's own tumor. The study will be conducted in patients with poor prognosis melanoma but minimal disease (stage II, post-surgery). The vaccine contains multiple MAAs partially purified from surface material shed into medium by four lines of melanoma cells grown in serum-free medium. The cells have been selected because they express different cell-surface MAAs. HLA-DR antigens have been removed by ultra-centrifugation. The vaccine will be administered intradermally in escalating doses for eight weeks and periodically thereafter for two years or to disease recurrence. The vaccine will be given without adjuvant to an initial group of ten patients, with pretreatment with cellular immunity to melanoma being measured sequentially after immunization and compared to levels of reactivity prior to immunization. Patients will be examined for side effects and presence of tumor on each visit. To date the vaccine has been given to over 30 patients. It appears to be safe since no adverse effects have been seen in any patients. It appears to be immunogeneic, since humoral and/or cellular immune responses to melanoma have been induced or augmented in over half of the immunized patients. (IT)
Showing the most recent 10 out of 19 publications
