Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.
Biological: Xenogeneic Tyrosinase DNA Vaccine
Device: TriGrid Delivery System for Intramuscular Electroporation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma|
- 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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Assess patients with measurable tumor for evidence of anti-tumor response following immunization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
|Experimental: Xenogeneic Tyrosinase||Biological: Xenogeneic Tyrosinase DNA Vaccine Device: TriGrid Delivery System for Intramuscular Electroporation|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471133
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Jedd D. Wolchok, MD, PhD||Memorial Sloan Kettering Cancer Center|