Single-Dose, Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 (90Y-hu3S193) in Patients With Advanced Ovarian Cancer

Date de début de l'étude : 1 novembre 2003

Inclusion Criteria 1. Histologically confirmed non-mucinous ovarian adenocarcinoma. 2. Persistent or recurrent intraperitoneal cancer following platinum/taxane-based therapy for Stage 3 ovarian cancer. 3. Patients with residual disease \< 2cm will be candidates for this study. 4. The following laboratory and clinical results within the last 2 weeks prior to study day 1: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; Platelet count ≥ 100 x 10\^9/L; Serum bilirubin ≤ 2.0 mg/dL; Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum creatinine ≤2.0 mg/dL; Forced expiratory volume (FEV1) ≥60% of predicted; Forced vital capacity (FVC) ≥60% of predicted; Diffusion capacity ≥55% of predicted; Left ventricular ejection fraction (LVEF) ≥50%; 5. Karnofsky performance status ≥ 70. 6. Before any trial-specific procedures or treatment can be performed, the patient or legally authorized guardian or representative must give witnessed written informed consent for participation in the trial. 7. Placement of an intra-abdominal catheter at the time of surgery. Exclusion Criteria 1. Active parenchymal disease (i.e., Stage IV International Federation of Gynecology and Obstetrics (FIGO) classification). 2. Presence of symptomatic extra abdominal metastases. 3. Known central nervous system (CNS) tumor involvement. 4. Clinically significant heart disease (New York Heart Association Class III or IV). 5. ECG demonstrating clinically significant arrhythmias or evidence of prior myocardial infarction. 6. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders that may limit the amount of antibody they can tolerate or render them ineligible for surgery. 7. Chronic inflammatory bowel disease. 8. Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior to enrollment. 9. Pregnancy or lactation. 10. Patients who are positive for human anti-human antibodies (HAHA) and/or who have received a murine monoclonal antibody.