Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer
NCT00006099CI-TRIAL-00070182terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low study accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monoclonal antibody hu3S193 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraperitoneal (IP) Infusion of 111In-hu3S193
- description
- 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.
- interventionNames
- Biological: Monoclonal antibody hu3S193
- type
- EXPERIMENTAL
- label
- Intravenous Infusion of 111In-hu3S193
- description
- 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.
- interventionNames
- Biological: Monoclonal antibody hu3S193
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.