drugset / Trial / NCT01300858
A Study of the Safety and Biological Activity of Intraperitoneal (IP) EGEN-001 Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells.
Timeline
- Start
- 2011-06
- Primary completion
- 2014-07
- Completion
- 2014-07
Outcome
Outcome not reported
Stopped (Enrollment): “Sites could not enroll patients.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EGEN-001 | Other / unclassified | 24 mg/m2 | Other |