| Eligibility |
Inclusion Criteria:
1. Subjects must have a suspected diagnosis of high grade epithelial ovarian, fallopian
tube, or primary peritoneal carcinoma with histologic confirmation to be obtained by
diagnostic laparoscopy.
2. Subjects must have an International Federation of Gynecology and Obstetrics (FIGO)
stage of III or IV who based on standard of care clinical considerations have been
recommended to undergo neoadjuvant therapy per standard clinical determination by
their oncology provider.
3. Only subjects with high grade serous adenocarcinoma histologic epithelial cell type
determined at diagnostic laparoscopy are eligible, poorly differentiated carcinomas
consistent with high grade serous histology are eligible. Pathologic diagnosis may be
via frozen section or permanent pathology.
4. Subjects must have adequate: bone marrow function, renal function, hepatic function,
and neurologic function.
5. Subjects should be free of active infection requiring isolation, parenteral
antibiotics or a serious uncontrolled medical illness or disorder within four weeks of
study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after
positive test or onset of symptoms.
6. 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.
7. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group
(ECOG) criteria.
8. Subjects of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of protocol therapy and agree to practice an effective form
of contraception. If applicable, subjects must discontinue breastfeeding prior to
study entry.
9. Subjects must have satisfactory results for the baseline laboratory analyses and
diagnostic procedures as specified in the protocol.
10. Subjects must have signed an IRB-approved informed consent and authorization
permitting release of personal health information.
Exclusion Criteria:
1. Subjects who have received prior treatment with IMNN-001.
2. Subjects who have a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to IMNN-001 or other drugs used in this study.
3. Subjects who have received oral or parenteral corticosteroids within 2 weeks of study
entry or who have a clinical requirement for ongoing systemic immunosuppressive
therapy such as chronic steroid (prednisone equivalent of > 10 mg/day) use not related
to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is
allowed.
4. Subjects with autoimmune disease requiring immunosuppressive therapy within the last 2
years. Examples of autoimmune disease include systemic lupus erythematosus, multiple
sclerosis, inflammatory bowel disease and rheumatoid arthritis.
5. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus
(HTLV) infections are excluded.
6. Subjects with other invasive malignancies are excluded if there is any evidence of the
invasive malignancy being present within the last three years. Subjects are also
excluded if their previous cancer treatment contraindicates this protocol therapy.
Subjects with non-invasive malignancies such as non-melanoma skin cancer, melanoma
in-situ, etc. are eligible.
7. Subjects 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, if it was completed more than three years prior to
registration, and the subject remains free of recurrent or metastatic disease.
8. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are
excluded. Subjects 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 subject remains free of recurrent or metastatic disease.
9. Subjects with known active hepatitis.
10. Subjects with nephrotic syndrome (proteinuria Grade 2 or greater).
11. Subjects with concurrent severe medical problems unrelated to the malignancy that
would significantly limit full compliance with the study or expose the subject to
extreme risk or decreased life expectancy.
12. Subjects with clinically significant cardiovascular disease.
13. Subjects of childbearing potential, not practicing adequate contraception, subjects
who are pregnant, or subjects who are breastfeeding are not eligible for this trial.
14. Subjects 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.
15. Subjects with a history of diverticulitis. Diverticulosis is not exclusionary.
16. Subjects having hemoptysis within the last month.
17. Subjects 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, fistulas, or suspected extensive adhesions from prior history or finding
at laparoscopy.
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