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

NCT01300858 ↗

Phase 1/2 Terminated 4 enrolled EGEN, Inc.
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

EvaluationDrugModalityDoseRoute
Subject EGEN-001 Other / unclassified 24 mg/m2 Other

Indications