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)
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.
|Study start date||2015-09-24|