Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer, male breast cancer
Brief summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer.
Detailed description
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.
Interventions
BIOLOGICALfilgrastim
PROCEDUREautologous bone marrow transplantation
PROCEDUREperipheral blood stem cell transplantation
RADIATIONindium In 111 monoclonal antibody BrE-3
RADIATIONyttrium Y 90 monoclonal antibody BrE-3
Sponsors
Cancer Research Institute of Contra Costa
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * BrE-3 positive * Relapsed or refractory disease with tumor progression after effective therapy allowed * Measurable or evaluable disease * Received at least one prior chemotherapy regimen for metastatic disease and have at least one of the following: * Chemotherapy refractory liver metastases more than 2 cm * Multiple non-resectable liver metastases * Brain metastases * Prior high-dose chemotherapy * Relapse within prior radiotherapy field * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Male or female Menopausal status: * Not specified Performance status: * 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm3 * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 2 times normal * SGOT/SGPT less than 2 times normal Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * LVEF greater than 45% by MUGA scan Pulmonary: * DLCO and FEV 1.0 greater than 60% predicted Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to E. coli derived proteins * No other comorbid condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior high-dose chemotherapy with autologous peripheral blood stem cell transplantation Chemotherapy: * See Disease Characteristics * See Biologic therapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * Recovered from prior therapy
Countries
United States
Outcome results
None listed