Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00072410|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Radiation: yttrium Y 90 monoclonal antibody Hu3S193||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Single-Dose, Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 (90Y-hu3S193) in Patients With Advanced Ovarian Cancer|
|Study Start Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072410
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Chaitanya R. Divgi, MD||Memorial Sloan Kettering Cancer Center|