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

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unither Pharmaceuticals
• Treatments: Oregovomab

Criteria

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.