Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Giving radiolabeled monoclonal antibody directly into the abdominal cavity may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody therapy directly into the abdominal cavity in treating patients who have advanced ovarian epithelial cancer.


Study summary:

OBJECTIVES: Primary - Determine the safety and maximum tolerated dose of intraperitoneal yttrium Y 90 monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193) in patients with advanced ovarian epithelial cancer. Secondary - Determine the localization and whole body and abdominal clearance of this drug in these patients using indium In 111 monoclonal antibody Hu3S193 and gamma camera imaging. - Determine the serum pharmacokinetics of Y90 MOAB Hu3S193 in these patients using gamma well counting. - Determine the antibody response in patients treated with this drug. OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193). Patients receive intraperitoneal (IP) technetium Tc 99m sulfur colloid and undergo abdominal imaging on day 1. Provided distribution of technetium Tc 99m sulfur colloid is deemed adequate, patients then receive IP Y90 MOAB Hu3S193 and IP indium In 111 monoclonal antibody Hu3S193 (for imaging) over 30 minutes on day 1. Within 3-5 hours after antibody administration, patients undergo whole body imaging and single-photon emission-computed tomography (SPECT) imaging of the abdomen and pelvis. Cohorts of 3-6 patients receive escalating doses of Y90 MOAB Hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for at least 2 years and then every 6 months for up to 5 years. PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed non-mucinous ovarian adenocarcinoma - Persistent or recurrent intraperitoneal disease after platinum/taxane-based therapy for stage III ovarian cancer - No active parenchymal disease (stage IV) - No symptomatic extraabdominal metastases - No known CNS tumor involvement PATIENT CHARACTERISTICS: Age - Any age Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding disorders Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - LVEF at least 50% - No New York Heart Association class III or IV heart disease - No clinically significant arrhythmia by ECG - No evidence of prior myocardial infarction Pulmonary - FEV_1 at least 60% of predicted - FVC at least 60% of predicted - Diffusion capacity at least 55% of predicted Other - Not pregnant or nursing - Negative pregnancy test - No other serious illness that would preclude study participation - No serious infection requiring antibiotics - No chronic inflammatory bowel disease - Human antimouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No prior murine monoclonal antibody therapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No immunosuppressive therapy for 30 days after the administration of yttrium Y 90 monoclonal antibody Hu3S193


NCT ID:

NCT00072410


Primary Contact:

Principal Investigator
Chaitanya R. Divgi, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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