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

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.

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