MedTrace Logo

Safety Study of phIL-12-005/PPC to Treat Recurrent Ovarian Cancer

NCT00137865 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-02-28

No results posted yet for this study

Summary

Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the cells of the body. Because the genes are damaged, the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the human gene for interleukin-12 \[IL-12\] (a cytokine) in a special carrier system designed to enter the cells and help the body produce cytokines.

This study has two purposes; the first is to determine what different strengths of EGEN-001 can be given safely without major side effects, and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer.

Conditions

  • Ovarian Neoplasms

Interventions

GENETIC

EGEN-001 (phIL-12-005/PPC)

Sponsors & Collaborators

  • EGEN, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Alvarez, MD · Divison of Gynecologic Oncology at University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00137865 on ClinicalTrials.gov