Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer
OBJECTIVES: I. Determine the safety of indium In 111 monoclonal antibody Hu3S193 (In 111
MOAB Hu3S193) given intraperitoneally OR intravenously in patients with ovarian carcinoma.
II. Compare the localization of In 111 MOAB Hu3S193 in ovarian cancer tissue after
intraperitoneal vs intravenous injection. III. Compare the biodistribution and
pharmacokinetics of this drug when administered intraperitoneally vs intravenously in these
patients. IV. Determine the antibody response in these patients to this drug.
OUTLINE: Patients are assigned to 1 of 2 treatment arms on a first come sequential basis.
Arm I: Patients receive indium In 111 monoclonal antibody Hu3S193 (In 111 MOAB Hu3S193)
intraperitoneally over 30 minutes. Arm II: Patients receive In 111 MOAB Hu3S193 IV over 30
minutes. Patients undergo surgical debulking 3-7 days following In 111 MOAB Hu3S193
administration, and biopsy samples are obtained to assess radioactive uptake.
Immunohistochemistry is also performed. Blood samples are obtained to assess serum
radioactivity. Whole body imaging is performed 3 hours after infusion of radiolabeled
monoclonal antibody, on the day of surgery, and at one time point in between. Patients are
followed for 30 days.
PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.
Primary Purpose: Diagnostic
Chaitanya R. Divgi, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|