EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT01489371|
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Cystadenocarcinoma Ovarian Undifferentiated Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Other: Laboratory Biomarker Analysis Biological: PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1 Drug: Pegylated Liposomal Doxorubicin Hydrochloride||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 9, 2012|
|Actual Primary Completion Date :||December 30, 2014|
|Actual Study Completion Date :||January 27, 2018|
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: Laboratory Biomarker Analysis
Biological: PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
- First course DLTs [ Time Frame: 28 days ]
- The grade of toxicity as assessed by CTCAE v 4.0 [ Time Frame: Up to 1 year ]
- Objective tumor response (complete and partial response) [ Time Frame: Up to 1 year ]
- Change in biomarker levels [ Time Frame: Baseline to up to 1 year ]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 ]Descriptive statistics and graphics will be used to examine the time course of changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489371
|United States, Alabama|
|University of Alabama at Birmingham Cancer Center|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|UC Irvine Health/Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87102|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Premal H Thaker||NRG Oncology|