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Pancreatic Adenocarcinoma - Healing Genes
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Pancreatic Adenocarcinoma

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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


Phase 1

DESCRIPTION:

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:

  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.

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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. A single intratumoral (into the tumor) injection of the engineered virus drug
  3. 2 days after, patient begins 7 days of prodrug therapy (oral medication)
  4. 14 days after step (3), chemotherapy may be administered
  5. 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
  6. 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.

Contacts:

David Kwon, MD | [email protected] | 313-916-9930

Janice Freytag, BS | [email protected] | 313-874-8236

 

SPONSOR INFORMATION:

Henry Ford Health System

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03281382

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