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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Correlative studies
Given intraperitoneally
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
...and 1 more locations
Patients Who Survive Progression-free for at Least 6 Months
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression
Time frame: Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years
Patients Who Have Objective Tumor Response (Complete or Partial Response)
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: CT or MRI used to follow lesion for measurable disease every other cycle. Patient's best response while on study treatment was recorded, Up to 5 years
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Adverse events are listed by adverse event and grade. The number of participants affected is listed.
Time frame: All Adverse Events (AEs) deemed at least possibly related to study treatmetn occurring during treatment and up to 30 days after stopping the study treatment. for up to 5 years after stopping study treatment
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Time frame: The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 years
Progression-free Survival
The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.
Time frame: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
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