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Prostate Cancer - Healing Genes
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Prostate Cancer

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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


Phase 1

DESCRIPTION:

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:

  1. 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
  2. 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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. A single intraprostatic injection of the investigatory drug
  3. Close observation of dose tolerance for 30 days
  4. 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.

Contacts:

Hans Stricker, MD | [email protected] | 313-916-7658

Farzan Siddiqui, MD, PhD | [email protected] | 313-916-1021

 

SPONSOR INFORMATION:

Henry Ford Health System

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02555397

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