A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
This study is designed to evaluate administration of a xenogeneic DNA vaccine encoding the
melanosomal antigen tyrosinase by in vivo electroporation in patients with malignant
melanoma. The objectives of the study are to characterize the safety and immunogenicity of a
DNA vaccine encoding the murine tyrosinase gene delivered administered intramuscularly using
the electroporation based TriGrid Delivery System (Ichor Medical Systems). We will assess
the nature, frequency, and severity of any toxicity associated with vaccination at
escalating pINGmuTyr doses and then expand enrollment at then expand enrollment at the
Maximum Tolerated Dose to assess immunologic responses to the tyrosinase antigen.
The hypotheses being tested are that the procedure is feasible and safe and that it induces
immune responses specific for tyrosinase in patients with stage IIB-IV malignant melanoma.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma.
Jedd D. Wolchok, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|