EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Laboratory Biomarker Analysis; PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1
Intervention description: Correlative studies; Given intraperitoneally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or
             primary peritoneal carcinoma; histologic documentation of the original primary tumor
             is required via the pathology report

          -  All patients must have measurable disease as defined by Response Evaluation Criteria
             in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion
             that can be accurately measured in at least one dimension (longest diameter to be
             recorded); each lesion must be >= 10 mm when measured by computed tomography (CT),
             magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm
             when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured
             by CT or MRI; patients must have evidence of intra-abdominal/pelvic disease; patients
             with disease exclusively located outside of the abdominal/pelvic cavity are not
             eligible

          -  Patient must have at least one "target lesion" to be used to assess response on this
             protocol as defined by RECIST 1.1; 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 at least 90 days following completion of radiation
             therapy

          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
             protocol, if one exists; in general, this would refer to any active GOG phase III
             protocol for the same patient population

          -  Patients who have received one prior regimen must have a GOG performance status of 0,
             1, or 2

               -  Patients who have received two prior regimens must have a GOG performance status
                  of 0 or 1

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy:

               -  Patients should be free of active infection requiring antibiotics (with the
                  exception of uncomplicated urinary tract infection [UTI])

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration; continuation of hormone replacement therapy
                  is permitted

               -  Any other prior therapy directed at the malignant tumor, including chemotherapy,
                  biologic/targeted therapy and immunologic agents, must be discontinued at least
                  three weeks prior to registration

          -  Patients must have had one 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, non-cytotoxic agents or extended therapy administered after
             surgical or non-surgical assessment

          -  Patients who have received only one prior cytotoxic regimen (platinum-based regimen
             for management of primary disease), must have a platinum-free interval of less than 12
             months, or have progressed during platinum-based therapy, or have persistent disease
             after a platinum-based therapy

          -  Patients are allowed to receive, but are not required to receive, one additional
             cytotoxic regimen for management of recurrent or persistent disease according to the
             following definition:

               -  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

               -  Note: patients on this non-cytotoxic study are allowed to receive additional
                  cytotoxic chemotherapy for management of recurrent or persistent disease, as
                  defined above; however, due to the novel nature of biologic compounds, patients
                  are encouraged to enroll on second-line non-cytotoxic studies prior to receiving
                  additional cytotoxic therapy

          -  Absolute neutrophil count (ANC) greater or equal to 1,500/mcl

          -  Platelet count greater or equal to 100,000/mcl

          -  Creatinine less than or equal to 1.5 x upper limit of normal (ULN) OR calculated
             creatinine clearance greater than or equal to 50 mL/min; any evidence of renal
             obstruction must be corrected prior to treatment

          -  Bilirubin less than or equal to 1.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) less
             than or equal to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for
             Adverse Events (CTCAE) grade 1

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients must meet pre-entry requirements

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             the study entry and be practicing an effective form of contraception

        Exclusion Criteria:

          -  Patients who have had previous treatment with EGEN-001

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies as noted above are excluded
             if there is any evidence of other malignancy being present within the last three
             years; patients are also excluded if their previous cancer treatment contraindicates
             this protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary
             peritoneal cancer within the last three years are excluded; prior radiation for
             localized cancer of the breast, head and neck, or skin is permitted, provided that it
             was completed more than three years prior to registration, and the patient remains
             free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within
             the last three years are excluded; patients may have received prior adjuvant
             chemotherapy for localized breast cancer, provided that it was completed more than
             three years prior to registration, and that the patient remains free of recurrent or
             metastatic disease

          -  Patients with a past history of primary endometrial cancer are excluded unless all of
             the following conditions are met: stage not greater than I-B; no more than superficial
             myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated
             subtypes, including papillary serous, clear cell or other International Federation of
             Gynecology and Obstetrics (FIGO) grade 3 lesions

          -  Patients with a serious uncontrolled medical illness or disorder, abdominal surgery
             (for reasons other than IP port placement) or active infection within four weeks of
             study entry; patients may have surgery for the purpose of IP port placement greater
             than or equal to one week(s) before study entry and treatment

          -  Patients with any condition/anomaly that would interfere with the appropriate
             placement of the IP catheter for study drug administration including: abdominal
             surgery within 4 weeks of study entry (for reasons other than IP port placement),
             intestinal dysfunction or suspected extensive adhesions from prior history or finding
             at laparoscopy

          -  Patients who are pregnant or breastfeeding