Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Male or female
- •Menopausal status:
- •Not specified
- •Performance status:
- •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
- •Bilirubin less than 2 times normal
- •SGOT/SGPT less than 2 times normal
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •LVEF greater than 45% by MUGA scan
- •DLCO and FEV 1.0 greater than 60% predicted
- •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
- •Not specified
- •Recovered from prior therapy
排除标准
- 未提供