Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer
NCT02555397 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-10-10
Summary
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
Conditions
Interventions
- BIOLOGICAL
-
Ad5-yCD/mutTKSR39rep-hIL12
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1
Sponsors & Collaborators
-
Henry Ford Health System
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2019-06-16
- Completion
- 2024-01-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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