Clinical Trial for Ovarian Cancer (OvaRex®)

Exclusion Criteria

• •Patients who have received more than one prior regimen of chemotherapy. A change in chemotherapy agents is permitted during the patient's primary therapy provided that the change is considered to be part of the initial chemotherapy treatment regimen.
• •Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian, tubal, or peritoneal origin requiring chemotherapy.
• •Patients who have compromised hematopoietic function (hemoglobin \<8.0 g/dL; lymphocyte count \<300 mm³; neutrophil count \<1000 mm³; platelet count \<100,000 mm³.
• •Patients with 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.
• •Patients with severe renal dysfunction defined as a serum creatinine \>1.6 mg/dL.
• •Patients with a 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.
• •Patients who have contraindications to the use of pressor agents.
• •Patients being chronically treated with immunosuppressive drugs such as cyclosporin, ACTH, or systemic corticosteroids.
• •Patients who have received immunotherapy (interferons, tumor necrosis factor, other cytokines \[e.g., interleukins\] or biological response modifiers, or BCG vaccines) within 6 weeks of receiving their first dose of study medication. Patients who have received hemopoietic factors are acceptable.
• •Patients who have had a splenectomy.
• •Patients with uncontrolled diseases other than cancer will be excluded. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
• •Patients who have a concurrent illness or chronically taking medication, which would confound the results of the study, preclude the patient from completing the study, or mask an adverse reaction.
• •Patients who have a concurrent malignancy (except non-melanoma of the skin, in situ carcinoma of cervix), unless the patient received curative treatment and has been disease free for greater than or equal to 5 years.
• •Patients receiving other investigational drugs within 30 days of enrollment.