Spots Global Cancer Trial Database for EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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Trial Identification
Brief Title: EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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
Study ID: NCT01118052
Study Description
Brief Summary: This phase II trial studies the side effects and how well EGEN-001 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come back. Biological therapies, such as EGEN-001, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the proportion of patients who survive progression-free for at least 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. II. To determine the frequency and severity of adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival and overall survival. TERTIARY OBJECTIVES: I. To collect blood and peritoneal lavage fluid from patients that will be stored for future research. OUTLINE: 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. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Gynecologic Oncology Group of Arizona, Phoenix, Arizona, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Case Western Reserve University, Cleveland, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Ronald Alvarez
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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