Safety Study of phIL-12-005/PPC to Treat Recurrent Ovarian Cancer
Ovarian Neoplasms
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Experimental
EGEN-001