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

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.