Finding studies
Finding studies
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Lead
Cancer Research Institute of Contra Costa
OBJECTIVES: * 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 regimen. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted