Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer

CDR0000068107

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving monoclonal antibodies in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian cancer.

2000-08-02

2002-02-26

2002-08-12

Terminated

Early phase I

1

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2023-10-04