A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
19 Years
N/A
Female
Ovarian Neoplasms
Trial Information
A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
EGEN-001-101 is a Phase 1, open label, non-randomized, dose escalation study in up to 18
(eighteen) patients (three to six patients in each of the first three cohorts, and up to
nine patients in a fourth cohort or MTD). The fourth cohort (or MTD, if earlier) will be
expanded in increments of three patients until a total of 18 patients have been enrolled.
Each patient will provide written dated informed consent prior to undergoing eligibility
screening for entry into the study. Screening evaluations will be performed within 21 days
prior to scheduled study drug administration. If all eligibility criteria are met, the
patient will be enrolled and will be scheduled for placement of the IP catheter at least 7
days prior to the scheduled dosing (Day -7) to allow adequate time for healing around the
catheter insertion site. Baseline evaluations will be performed prior to dosing. At that
time the investigator will ensure that the patient remains eligible for participation.
All study drug will be administered on an inpatient basis and the patient will remain
confined for 24 hours following study drug administration for evaluation of safety and
collection of specified body fluid samples for plasmid IL-12-DNA and cytokine
determinations. Each patient will receive the same dose of EGEN-001 once weekly for four
weeks (administered on Day 0, Day 7, Day 14, and Day 21). Patients will undergo safety
evaluations 1, 4 and 24 hours and 3 days following each dose. Patients will return to the
clinic for safety evaluations three days, one week and five weeks (± one week) following the
last dose.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
Yes
Principal Investigator
Ronald Alvarez, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Divison of Gynecologic Oncology at University of Alabama at Birmingham
Authority:
United States: Food and Drug Administration
Study ID:
EGEN-001-101
NCT ID:
NCT00137865
Start Date:
August 2005
Completion Date:
October 2006
Related Keywords:
- Ovarian Neoplasms
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
