EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01118052
First received: May 5, 2010
Last updated: December 16, 2013
Last verified: December 2013
  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. Biological therapies, such as EGEN-001, may stimulate the immune system in different ways and stop tumor cells from growing.

Funding Source - FDA OOPD


Condition Intervention Phase
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Biological: EGEN-001
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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) (IND #14350) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Proportion of patients who survive progression-free [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients who have objective tumor response (complete or partial), assessed using RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
    Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.

  • Overall survival [ 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 ] [ Designated as safety issue: No ]
    Characterized with Kaplan-Meier plots and estimates of the median time until death.


Estimated Enrollment: 56
Study Start Date: November 2010
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (EGEN-001)
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.
Biological: EGEN-001
Given intraperitoneally
Other Name: phIL-12-005/PPC
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

    • Recurrent or persistent disease
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam or as ≥ 20 mm by chest x-ray

    • Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI
  • Patients must have evidence of intraabdominal/pelvic disease

    • No patients with disease exclusively located outside of the abdomen/pelvic cavity
  • At least 1 "target lesion" to be used to assess response

    • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
  • Not eligible for a higher priority GOG trial, if one exists (e.g., any active GOG phase III trial for the same patient population)
  • Received 1 prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound (this initial treatment may have included intraperitoneal therapy, consolidation, noncytotoxic agents, or extended therapy administered after surgical or nonsurgical assessment)

    • Patients who have received only 1 prior cytotoxic regimen (platinum-based regimen for the management of primary disease) must meet 1 of the following criteria:

      • Platinum-free interval < 12 months
      • Progressed during platinum-based therapy
      • Persistent disease after a platinum-based therapy
  • GOG performance status 0-2 (for patients who have received 1 prior regimen) OR 0-1 (for patients who have received 2 prior regimens)
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 1.5 times ULN
  • AST ≤ 3 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics (except for uncomplicated urinary tract infection)
  • Any evidence of renal obstruction must be corrected before study treatment
  • No neuropathy (sensory or motor) > CTCAE grade 1
  • No history of other invasive malignancies, except for any of the following:

    • Nonmelanoma skin cancer
    • Localized cancer of the breast, head and neck, or skin provided there is no evidence of the disease for ≥ 3 years
  • No history of endometrial cancer unless all of the following criteria are met:

    • Stage not greater than IB
    • No more than superficial myometrial invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
  • No serious uncontrolled medical illness or disorder or active infection within the past 4 weeks
  • No condition or anomaly that would interfere with the appropriate placement of the intraperitoneal catheter for study drug administration, including intestinal dysfunction or suspected extensive adhesions from prior history or finding at laparoscopy
  • No concurrent amifostine or other protective reagents
  • One additional cytotoxic regimen for the management of recurrent or persistent disease is allowed

    • Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
    • Patients on this study may receive additional cytotoxic chemotherapy for the management of recurrent or persistent disease, as defined above
  • Patients are allowed to receive, but are not required to receive, biologic/targeted therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, one biologic/targeted therapy for recurrent disease (either alone or in combination with chemotherapy)
  • Recovered from the effects of recent surgery, radiotherapy, or chemotherapy
  • No prior EGEN-001
  • No prior cancer treatment that contraindicates study treatment
  • More than 3 years since prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

    • Prior adjuvant chemotherapy for localized breast cancer is allowed provided that it was completed > 3 years ago and that the patient remains free of recurrent or metastatic disease
  • More than 3 years since prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

    • Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed provided that it was completed > 3 years ago and that the patient remains free of recurrent or metastatic disease
  • More than 4 weeks since prior abdominal surgery (for reasons other than intraperitoneal port placement)

    • At least 1 week since surgery for the purpose of intraperitoneal port placement
  • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Continuation of hormone replacement therapy is allowed
  • At least 3 weeks since any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted therapy and immunologic agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118052

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Ronald Alvarez Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01118052     History of Changes
Other Study ID Numbers: GOG-0170Q, NCI-2011-02041, FD-R-003942, CDR0000672159, GOG-0170Q, GOG-0170Q, U10CA027469
Study First Received: May 5, 2010
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 22, 2014