Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional diagnostic trial for Ovarian Cancer focused on measuring ovarian epithelial cancer
Eligibility Criteria
Inclusion Criteria Cytologic or pathologic diagnosis consistent with ovarian carcinoma. Scheduled to undergo surgical evaluation. Karnofsky performance status of > 60%. Adequate organ function as defined by: Absolute neutrophil count (ANC) > 1.5 x 10^9/L Platelet count > 100 x 10^9/L Bilirubin < 2.0 mg/dL Aspartate aminotransferase (AST) and Alanine transaminase (ALT) < 2.5 X upper limit of normal Serum creatinine < 2.0 mg/dL Forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)> 70% of predicted Left Ventricular Ejection Fraction >50% Recovered from the toxicity of any prior therapy. No evidence of active infection which requires antibiotic therapy. > 18 years of age. Able to sign written informed consent. Exclusion Criteria Any significant intercurrent medical problems which may limit the amount of antibody they can tolerate, or render them ineligible for surgery. Clinically significant cardiac disease (New York Heart Association Class III/IV, or abnormalities on ECG that are considered by the investigator to place the patient at increased risk), severe debilitating pulmonary disease, active infections or coagulation disorders. Survival expectancy less than 12 weeks. History of autoimmune hepatitis or history of autoimmune disease. Chemotherapy, radiotherapy, or immunotherapy within four weeks prior to receiving hu3S193. Psychiatric, addictive or other disorders that compromise the ability to give informed consent.
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Intraperitoneal (IP) Infusion of 111In-hu3S193
Intravenous Infusion of 111In-hu3S193
Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In. Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline.
Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.