Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer

The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy.

Study Type: Interventional

Study Design: Endpoint Classification: Safety Study

Intervention Model: Single Group Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title: Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate CancerAfter Definitive Radiotherapy

Estimated Enrollment: 15

Study Start Date: August 2015

Estimated Study Completion Date: August 2019

Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Arms:

Experimental: Single
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.