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

NCT00137865 | Terminated Phase 1

• 1 other identifier: EGEN-001-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer

Secondary Outcomes (3)

• To assess the preliminary efficacy of EGEN-001 by monitoring detectable tumor burden in patients with recurrent epithelial cancer

• To assess EGEN-001 distribution by measuring human interleukin-12 plasmid (phIL-12) DNA copy number in the blood and peritoneal fluid

• To assess the biological effects of EGEN-001 on cytokine production by measuring interferon (IFN) gamma and interleukin-12 (IL-12) concentrations in the blood and peritoneal fluid

Study Arms (1)

EGEN-001

EXPERIMENTAL

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

Interventions

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

EGEN-001

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• EGEN, Inc.: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

GEN-1

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Ronald Alvarez, MD

  Divison of Gynecologic Oncology at University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: August 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)