EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Intraperitoneal Egen-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Pegylated Liposomal-Doxorubicin (PLD, Doxil (NSC# 712227 or Lipodox (NSC#673089) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
- First course DLTs [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- The grade of toxicity as assessed by CTCAE v 4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
- Objective tumor response (complete and partial response) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Change in biomarker levels [ Time Frame: Baseline to up to 1 year ] [ Designated as safety issue: No ]Descriptive statistics and graphics will be used to examine the time course of changes.
- Change in cellular immune response as measured by cell-specific RNA transcripts [ Time Frame: Baseline to up to 1 year ] [ Designated as safety issue: No ]Descriptive statistics and graphics will be used to examine the time course of changes.
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (EGEN-001, pegylated liposomal doxorubicin)
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and EGEN-001 IP over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: phIL-12-005/PPCDrug: pegylated liposomal doxorubicin hydrochloride
Other Names:Other: laboratory biomarker analysis
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of EGEN-001 when administered in combination with pegylated liposomal doxorubicin hydrochloride (PLD; Doxil; Lipodox) every 28 days and the associated DLTs based on adverse events that occur in cycle 1 for this combination in women with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
II. To examine the tolerability of the combination at the MTD of EGEN-001 assessed in combination with PLD.
III. To determine recommended phase II dose (RP2D) of EGEN-001 in combination with PLD.
I. To estimate the objective response rate (complete and partial) in patients with measurable disease.
I. Determine the levels and time course of interleukin-12 (IL-12), interferon-gamma (IFN-gamma), tumor necrosis factor-alpha (TNF-alpha) and vascular endothelial growth factor (VEGF) following EGEN-001 treatment.
II. Assess the effect of EGEN-001 treatment on the nature of the cellular immune responses by measuring cell-specific ribonucleic acid (RNA) transcripts.
OUTLINE: This is a dose-escalation study of EGEN-001.
Patients receive pegylated liposomal doxorubicin hydrochloride intravenously (IV) over 60 minutes on day 1 and EGEN-001 intraperitoneally (IP) over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up quarterly for up to 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489371
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Warner K. Huh 205-934-0309|
|Principal Investigator: Warner K. Huh|
|United States, California|
|University of California Medical Center At Irvine-Orange Campus||Recruiting|
|Orange, California, United States, 92868|
|Contact: Krishnansu S. Tewari 714-456-6191 firstname.lastname@example.org|
|Principal Investigator: Krishnansu S. Tewari|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: David G. Mutch 800-600-3606 email@example.com|
|Principal Investigator: David G. Mutch|
|United States, New Mexico|
|University of New Mexico||Recruiting|
|Albuquerque, New Mexico, United States, 87106|
|Contact: Teresa L. Rutledge 505-272-6972|
|Principal Investigator: Teresa L. Rutledge|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Steven E. Waggoner 800-641-2422|
|Principal Investigator: Steven E. Waggoner|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Robert S. Mannel 405-271-4272 firstname.lastname@example.org|
|Principal Investigator: Robert S. Mannel|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: William H. Bradley 414-805-4380|
|Principal Investigator: William H. Bradley|
|Principal Investigator:||Premal Thaker||Gynecologic Oncology Group|