A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients With Ovarian Epithelial Carcinoma

Inclusion Criteria:

* Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin.
* FIGO Stage III or IV prior to study.
* Serum CA125 level \>35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level \> or = 100 U/mL following surgery or immunohistochemical evidence of tumor tissue expressing CA125.
* Completed primary treatment following initial diagnosis, including chemotherapy involving a cisplatin or carboplatin-based regimen.
* Functional Performance Status \< or = 2 by ECOG scale.
* Medical assessment consistent with prognosis for an expected survival of at least 3 months.
* Voluntary participation, signed informed consent and willingness to complete all study procedures.

Exclusion Criteria:

* No surgery (not including minor surgical procedures), chemotherapy, or radiotherapy (whole abdomen, abdominopelvic or pelvic) within 4 weeks prior to first dose of study drug.
* No known refractory or recurrent disease requiring chemotherapy during the 4 weeks prior to, or planned 10 weeks after first study dose.
* Serum CA125 levels not \>800 U/mL at baseline evaluation.
* No gross (clinically evident) ascites.
* No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 4 weeks of first study dose.
* No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes or serum human anti-murine antibodies (HAMA) not above upper limit of normal at baseline evaluation.
* Not on long-term chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
* Ovarian tumors must be of low malignant potential or with noninvasive disease.
* No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of cervix), unless curative treatment was received and patient has been disease-free for \> or = 5 years.
* No known allergy to murine proteins, or prior documented anaphylactic reaction to any drug, or known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
* No previous splenectomy.
* No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn's Disease, MS, ankylosing spondylitis).
* No recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital immunodeficiencies.
* No uncontrolled diseases or illness other than this cancer.
* No significant cardiovascular abnormalities including uncontrolled hypertension, uncontrolled angina, uncontrolled arrhythmias, or CHF (NYHA Classes II-IV).
* No compromised hematopoietic function defined as a hemoglobin \<10.0 g/dL or lymphocyte count \<300 mm3 or neutrophil count \<1000 mm3 or platelet count \<100,000 mm3.
* No hepatic dysfunction defined as a bilirubin above upper limit of normal, LDH, SGOT and SGPT \>2 times upper limits of normal, or albumin \<3.5 g/dL.
* No renal dysfunction defined as serum creatinine above upper limit of normal.
* No pregnancy or breast-feeding (While pregnancy is unlikely in view of the disease and previous surgery, patients who 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.)
* No other investigational drugs within 30 days of enrollment.
* No contraindications present to the use of pressor agents.
* No HIV infection, or recent history of drug abuse, alcoholism, or hepatitis.