A Phase 1 interventional study of Xenogeneic Tyrosinase DNA Vaccine and TriGrid Delivery System for Intramuscular Electroporation in Melanoma (Skin) and Intraocular Melanoma, sponsored by Ichor Medical Systems Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-07.
Sponsored by Ichor Medical Systems Incorporated · Phase 1, Interventional, and Treatment
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.
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 24 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.
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Biological: Xenogeneic Tyrosinase DNA Vaccine · Device: TriGrid Delivery System for Intramuscular Electroporation
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
Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
Time frame: 6 months
Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients
Time frame: 6 months
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Ichor Medical Systems Incorporated