EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: Biological therapies, such as EGEN-001, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II clinical trial is studying the side effects and how well EGEN-001 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
- Proportion of patients who survive progression-free for ≥ 6 months [ Time Frame: 6 months post treatment iniation ] [ Designated as safety issue: No ]
- Proportion of patients who have objective tumor response (complete or partial) [ Time Frame: Every other cycle for first 6 months, then every 6 months or as needed ] [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by CTCAE [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
- Duration of progression-free survival and overall survival [ Time Frame: ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
EGEN-001 24mg/m2 weekly
|Biological: EGEN-001 Other: laboratory biomarker analysis|
- To estimate the proportion of patients who survive progression-free for ≥ 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with intraperitoneal EGEN-001.
- To determine the frequency and severity of adverse events as assessed by the NCI CTCAE version 4.0.
- To determine the duration of progression-free survival and overall survival.
- To collect blood and peritoneal lavage fluid from patients that will be stored for future research.
OUTLINE: This is a multicenter study.
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood and peritoneal fluid samples may be collected at baseline for translational research.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|United States, Alabama|
|UAB Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Maryland|
|Alvin and Lois Lapidus Cancer Institute at Sinai Hospital|
|Baltimore, Maryland, United States, 21215|
|United States, Massachusetts|
|Baystate Regional Cancer Program at D'Amour Center for Cancer Care|
|Springfield, Massachusetts, United States, 01199|
|United States, Mississippi|
|University of Mississippi Cancer Clinic|
|Jackson, Mississippi, United States, 39216|
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131-5636|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Lake/University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Utah|
|Huntsman Cancer Institute at University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Philip J. DiSaia, MD||Gynecologic Oncology Group|