Phase I Study Of Yttrium 90-Labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer
- Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody B3 followed by
autologous peripheral blood stem cell transplantation in patients with relapsed or
metastatic breast cancer.
- Determine the toxicity of this treatment regimen in these patients.
- Determine the clinical response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody B3 (Y90 MOAB
Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 4 days prior to
peripheral blood stem cell (PBSC) collection and continuing until the target number of cells
After PBSC collection, patients receive indium In 111 monoclonal antibody B3 IV over 30-60
minutes once within days -7 to -1 for tumor imaging and then Y90 MOAB B3 IV over 30-60
minutes on day 0. After at least day 7, patients undergo autologous PBSC reinfusion.
Patients receive G-CSF SC daily beginning 7 days after PBSC reinfusion and continuing until
blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB B3 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 at 1 week, 1 month, and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 24-36
Primary Purpose: Treatment
Claude Sportes, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Center for Cancer Research||Bethesda, Maryland 20892|