Phase 1 Trial of Interleukin 12 Gene Therapy for Metastatic Pancreatic Cancer
Phase 1 Trial Of Oncolytic Adenovirus-mediated Cytotoxic And Il-12 Gene Therapy In Combination With Chemotherapy For The Treatment Of Metastatic Pancreatic Cancer
Doctors at the Henry Ford Health System are investigating a treatment for metastatic pancreatic cancer. 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.
The prodrugs are second steps after a single injection of the investigatory drug to the tumor. A final, possible step may include chemotherapy and/or a marker visible under PET scan which can confirm the genes were inserted into the cancer cell’s DNA.
- Be 18 years of age or older
- Have a diagnosis of metastatic pancreatic adenocarcinoma
- Must have adequate starting organ function per laboratory assessments before the study
- Must agree to contraception during and at least 2 months after the gene therapy
- Not be pregnant or breastfeeding
- Not have Islet cell tumor, benign cyst, peri-ampullary carcinoma or any non-adenocarcinomas
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- A single intratumoral (into the tumor) injection of the engineered virus drug
- 2 days after, patient begins 7 days of prodrug therapy (oral medication)
- 14 days after step (3), chemotherapy may be administered
- On an optional basis, a special PET scan may take place requiring a marker to be administered, allowing for images of the viral distribution and intensity of the genes
- Follow up will continue for at least 3 weeks
LOCATIONS AND CONTACTS:
The study site is at Henry Ford Health System in Detroit, MI. Map.
David Kwon, MD | [email protected] | 313-916-9930
Janice Freytag, BS | [email protected] | 313-874-8236
Henry Ford Health System
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