Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)
研究概览
简要总结
RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, cyclosporine, and methotrexate before or after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin, high-dose melphalan, and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma of the breast.
- Determine the ability of this preparative regimen to facilitate long-term engraftment of allogeneic stem cells and lymphocytes in these patients.
- Determine the response in measurable/evaluable disease and its temporal relationship to the preparative chemotherapy used and to the onset of clinical graft-versus-host disease (GVHD) in patients treated with this regimen.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the tumor response and its temporal relationship to administration of high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen.
- Determine the frequency and durability of the induction of full donor chimerism of lymphocytes in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
treatment
干预措施: anti-thymocyte globulin (Biological)
treatment
干预措施: filgrastim (Biological)
treatment
干预措施: graft-versus-tumor induction therapy (Biological)
treatment
干预措施: therapeutic allogeneic lymphocytes (Biological)
treatment
干预措施: cyclosporine (Drug)
treatment
干预措施: fludarabine phosphate (Drug)
treatment
干预措施: melphalan (Drug)
treatment
干预措施: methotrexate (Drug)
treatment
干预措施: peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)
时间窗: 100 days post transplant
Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes
时间窗: 30 days post transplant
Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes based on cell counts of ANC \>1000 for 3 consecutive days and platelet count of \>50,000
Number of Participants With Adverse Events
时间窗: 5 years post transplant
次要结局
- Progression-free Survival(From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months)
- Overall Survival(1 year from the time of transplant)
- Response as Measured at 12 Months Post Allografting(From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting(1 month post allografting)
研究者
Edward Ball
MD
University of California, San Diego