Single-Dose, Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 (90Y-hu3S193) in Patients With Advanced Ovarian Cancer
- Determine the safety and maximum tolerated dose of intraperitoneal yttrium Y 90
monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193) in patients with advanced ovarian
- 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
- 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
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
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
Primary Purpose: Treatment
Chaitanya R. Divgi, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|