Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent, Platinum-Sensitive, Ovarian Cancer
Completed · Phase 1
Conditions studied: Ovarian Neoplasms
In brief
Ovarian 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, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA OOPD
Key facts
- Study ID
- NCT00473954
- Run by
- EGEN, Inc.
- People needed
- 13
- Starts
- 2007-04-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2013-03-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Be female and at least 18 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation);
- Histologically/cytologically confirmed epithelial ovarian cancer that meets one of the following criteria:
- measurable disease by computed tomography (CT) scan or
- malignant ascites, or
- Serum CA-125 levels; or
- Clinically evaluable recurrent disease by other criteria.
- Relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6 months since last exposure to platinum based therapy).
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1 or 2;
- Recovered from prior chemotherapy, having adequate bone marrow function:
- Adequate renal function;
- Adequate liver function;
- If of childbearing potential, have a negative pregnancy test and agree to follow an acceptable method of birth control;
- Agree to be compliant with the study's requirements;
- Understand and sign a written Informed Consent prior to the performance of any study-related procedures.
You may not qualify if…
- Ovarian cancer other than documented epithelial cancer;
- Intra-abdominal disease > 5 cm in diameter;
- Any serious, uncontrolled, intercurrent medical illness or disorder including, but not limited to:
- Autoimmune disorders
- Cardiac Disorders
- Diabetes
- Intrahepatic disease/cancer as documented by CT-scan
- An active infection within 4 weeks of study entry;
- Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
- Prior treatment with whole abdominal irradiation;
- Currently receiving or have received any investigational agents within 28 days of study entry;
- Received prior chemotherapy for ovarian cancer administered by the IP route;
- Received any chemotherapy between completion of primary chemotherapy for ovarian cancer and study entry (e.g. consolidation therapy);
- Receipt of immunotherapy and/or any medications with the potential to affect the activity of EGEN 001;
- Known history of HIV infection, hepatitis B, or hepatitis C;
- Known hypersensitivity to any of the components of carboplatin or docetaxel;
- Life expectancy of less than 3 months;
- Known, current, recreational drug or alcohol abuse;
- Breast feeding an infant;
- Psychiatric illness/social situations which would limit compliance with study requirements;
- Any other known condition which in the Investigator's opinion would make the patient a poor candidate for the study.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Oncology Specialties, PC — Huntsville, Alabama, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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