Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
- Determine the maximum tolerated dose of yttrium Y 90 labeled, humanized monoclonal
antibody BrE-3 when given in combination with indium In 111 labeled, humanized
monoclonal antibody BrE-3 followed by autologous bone marrow or peripheral blood stem
cell transplantation in patients with metastatic breast cancer.
- Determine hematopoietic engraftment in these patients treated with this regimen.
- Determine the ability of indium In 111 labeled, humanized monoclonal antibody BrE-3 to
image metastatic disease in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary antitumor response in these patients treated with this
OUTLINE: This is a dose escalation study of yttrium Y 90 labeled, humanized monoclonal
antibody BrE-3 (Y90 huMOAB BrE-3).
Patients receive Y90 huMOAB BrE-3 and indium In 111 labeled, humanized monoclonal antibody
BrE-3 IV over 1-2 hours on day -14. Patients undergo autologous bone marrow or peripheral
blood stem cell transplantation on day 0. Patients also receive filgrastim (G-CSF) IV
beginning on day 0 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 huMOAB BrE-3 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 toxicities.
Patients are followed every 3-4 months for 1 year and then at least annually thereafter.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Primary Purpose: Treatment
Roberto L. Ceriani, MD, PhD
Cancer Research Institute of Contra Costa
United States: Federal Government
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Cancer Research Institute of Contra Costa||San Francisco, California 94107|