The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer

This is an interventional treatment trial for Cancer of Ovary Read More

Inclusion Criteria:

1. Female subjects with CA125-associated, advanced ovarian cancer (FIGO Stage III/IV) previously treated and now presenting with recurrent or persistent disease.
2. Must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin that is persistent or progressive following multiple rounds of prior standard of care and experimental therapy.
3. Must have had an elevated serum CA125 level twice the upper limit of normal (per reference lab normal range) measured within 4 weeks of enrollment.
4. Must have measurable disease by radiographic or physical criteria suitable for evaluation according to RECIST v1.1 for documentation of disease response or progression.
5. Must have a Functional Performance Status of less than or equal to 2 on the ECOG scale (Appendix VII).
6. Must have reached legal age to consent.
7. Must have medical assessment consistent with prognosis for an expected survival of at least 6 months and be clinically appropriate to receive a 12 week hiatus from any cytotoxic treatment according to the best clinical judgement of the treating investigator.
8. Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.

Exclusion Criteria:

1. Compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte count <300 mm3; neutrophil count <1000 mm3; platelet count <100,000 mm3).
2. Hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
3. Renal dysfunction defined as a serum creatinine >1.6 mg/dL.
4. Pregnant or breast-feeding. (While pregnancy is unlikely in view of the disease and previous surgery, subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method).
5. Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy.
6. Known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
7. Chronically treated with systemic doses of immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
8. Active infection causing fever.
9. Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiencies, including HIV infection or have been splenectomized.
10. Uncontrolled diseases other than cancer will be excluded. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
11. Have received other investigational drugs within 30 days of enrollment.
12. Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use.
13. Unable to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to treatment.
14. Known to have recent history of drug abuse or alcoholism.
15. Have participated in a prior oregovomab clinical trial. Prior treatment with Hiltonol® does not exclude a subject from participation.