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

Stopped early · 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 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.

Key facts

Study ID

NCT00137865

Run by

EGEN, Inc.

People needed

18

Starts

2005-08-01

Expected to finish

2006-10-01

Last updated by the study team

2013-02-28

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female and at least 19 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation)
• Have received previous treatment for ovarian cancer that included a platinum based chemotherapy regimen
• Have recurrent epithelial ovarian cancer
• Have a measurable tumor by computed tomography (CT) scan according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Have an ECOG performance status score of 0, 1, or 2
• If of childbearing potential, agree to follow an acceptable method of birth control (e.g., abstinence, intrauterine device [IUD] or barrier method), as determined by the investigator, for the duration of the study. Hormonal contraceptives should not be used as the sole method of birth control.
• Have normal organ and marrow function as defined below:
• Leukocytes ≥ 3,000/µL;
• Absolute neutrophil count ≥ 1,500/µL;
• Platelets ≥ 100,000/µL;
• Total bilirubin within institutional limits;
• SGOT/SGPT ≤ 2.5 X institutional upper limit of normal (ULN);
• Creatinine within institutional normal limits; OR creatinine clearance ≥ 60mL/min/1.73m2 for patients with creatinine levels above institutional normal.
• Have electrocardiogram (ECG) without clinically significant abnormality, as determined by a qualified cardiologist
• Have the capability (caregiver) of performing IP site care while at home

You may not qualify if…

• A serious uncontrolled intercurrent medical illness or disorder including, but not limited to, ongoing or active infection, abdominal surgery, autoimmune disorders, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations which would limit compliance with study requirements
• Intraabdominal disease > 5 (five) centimeters in diameter
• Previous treatment with whole abdominal irradiation
• Intestinal dysfunction or suspected extensive adhesions from prior history or findings at laparoscopy
• Intrahepatic disease
• Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
• Received investigational agents within three months prior to study drug dosing
• Receipt of any medications (in particular, systemic or topical steroids) or substances known to affect, or with the potential to affect, the activity of EGEN-001
• Life expectancy of less than three months
• Known human immunodeficiency virus (HIV) infection
• Positive HbsAg
• Positive hepatitis C virus (HCV) serology
• Prior IP drug administration
• Prior immunotherapy for ovarian cancer
• Chemotherapy within four weeks prior to placement of IP catheter
• Radiotherapy within eight weeks prior to placement of IP catheter
• Contraindication (either allergy or impaired renal function) to injection with contrast media for adequate evaluation of tumor size by CT scan
• Pregnant or breast feeding an infant

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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