Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer
Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
Doctors at the Henry Ford Health System are investigating a treatment for prostate cancer that has recurred after radiation therapy. The therapy involves a single injection of a genetically engineered adenovirus to target and infect cancer cells, transferring to them 3 genes:
- Two genes that cause the tumor cells to self-destruct when in the presence of a “prodrug” or molecule necessary for the self-destruction, preventing the cancer cells from replicating
- A gene which produces natural immune factor to stimulate the immune system to defend against cancer – essentially calling forth an immune response to help
The virus is genetically engineered only to cause infection in the cancer cells, and to limit the production of the self-destruct genes and the immune factor (interleukin 12 or IL-12) to the tumor, where it is needed most.
- Be 18 years of age or older and male
- Have a diagnosis of prostate cancer but no evidence of metastatic disease
- Must agree to contraception for at least 3 months after the gene therapy
- Meet specific guidelines regarding the status of their disease
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- A single intraprostatic injection of the investigatory drug
- Close observation of dose tolerance for 30 days
- At least 2 years and up to 5 years follow up to measure cancer response and overall quality of life
LOCATIONS AND CONTACTS:
The study site is at Henry Ford Health System in Detroit, MI. Map.
Hans Stricker, MD | [email protected] | 313-916-7658
Farzan Siddiqui, MD, PhD | [email protected] | 313-916-1021
Henry Ford Health System
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