| Eligibility |
Inclusion Criteria:
1. Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or
primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or
interventional radiology or CT guided core biopsy. Histologic documentation of the
original primary tumor is required via the pathology report.
2. Patients with the following histologic epithelial cell types are eligible: High grade
serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear
cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise
specified (N.O.S.).
3. Patients must have adequate:
i. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony
stimulating factors. Platelets greater than or equal to 100,000/mcl.
ii. Renal function: Creatinine = 1.5 x institutional upper limit normal (ULN). iii.
Hepatic function: Bilirubin = 1.5 x ULN. SGOT (AST) and SGPT (ALT) = 3.0 x ULN and
alkaline phosphatase = 2.5 x ULN.
iv. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
4. Patients should be free of active infection requiring parenteral antibiotics or a
serious uncontrolled medical illness or disorder within four weeks of study entry.
5. Any hormonal therapy directed at the malignant tumor must be discontinued at least one
week prior to the first treatment. Continuation of hormone replacement therapy is
permitted.
6. Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative
Group (ECOG) criteria.
7. Patients of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of protocol therapy and be practicing an effective form of
contraception. If applicable, patients must discontinue breastfeeding prior to study
entry.
8. Patients must have satisfactory results for the baseline laboratory analyses and
diagnostic procedures as specified in the protocol.
9. Patients must have signed an IRB-approved informed consent and authorization
permitting release of personal health information.
10. Patients must be at least 18 years old.
Exclusion Criteria:
1. Patients who have received prior treatment with IMNN-001.
2. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to GEN-1 or other agents used in this study.
3. Patients who have received oral or parenteral corticosteroids within 2 weeks of study
entry or who have a clinical requirement for ongoing systemic immunosuppressive
therapy not related to chemotherapy administration.
4. Patients receiving treatment for active autoimmune disease. "Active" refers to any
condition currently requiring therapy. Examples of autoimmune disease include systemic
lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid
arthritis.
5. Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer and other specific malignancies as noted in the protocol 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.
6. Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis 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.
7. Patients who have received prior chemotherapy for any abdominal or pelvic tumor 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.
8. Patients with known active hepatitis.
9. Patients with concurrent severe medical problems unrelated to the malignancy that
would significantly limit full compliance with the study or expose the patient to
extreme risk or decreased life expectancy.
10. Patients of childbearing potential, not practicing adequate contraception, patients
who are pregnant, or patients who are breastfeeding are not eligible for this trial.
11. Patients with history or evidence upon physical examination of CNS disease, including
primary brain tumor, seizures not controlled with standard medical therapy, any brain
metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic
attack (TIA) or subarachnoid hemorrhage within six months of the first date of
treatment on this study.
12. 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.
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