Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.
详细描述
OBJECTIVES:
- Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation after an immunoablative conditioning regimen to induce a state of mixed host/donor chimerism in patients with metastatic breast cancer.
- Determine the ability of this treatment regimen to induce an allogeneic graft-versus-tumor response in these patients.
- Determine the feasibility of giving other approved therapies to these patients at the first sign of disease progression in order to stabilize or produce a minimal or partial response.
OUTLINE: Patients receive chemotherapy comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days 1-4. Patients receive filgrastim (G-CSF) SC daily beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 2 courses.
Patients receive a transplantation preparative regimen comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 (beginning on day 22 of immune-depleting chemotherapy) followed by allogeneic peripheral blood stem cell transplantation IV on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover, plus cyclosporine IV over 1-2 hours every 12 hours on days -1 to 14 and then orally until day 40.
Patients with persistent malignant disease and less than grade II acute graft-versus-host disease receive donor lymphocytes IV on days 42, 70, and 98.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Stage IV breast cancer
- •Measurable disease
- •Progressive disease
- •Increase in disease mass or less than partial response to therapy
- •At least one prior chemotherapy regimen for metastatic disease and progressed
- •Must have received prior therapy with a taxane and an anthracycline
- •Estrogen/progesterone receptor-positive patients must have received and progressed on at least one hormonal agent in adjuvant or metastatic setting
- •Her2-neu-expressing patients must have received and progressed on trastuzumab (Herceptin®) in adjuvant or metastatic setting
- •Prior autologous stem cell transplantation allowed if less than complete response or disease progression in adjuvant or metastatic setting
- •Consenting first-degree relative with at least 5 out of 6 HLA-antigen match (may include mismatch at the D locus)
- •Hormone receptor status:
- •Estrogen receptor status known
- •Progesterone receptor status known
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •Not specified
- •Bilirubin ≤ 2 mg/dL
- •SGOT < 4 times upper limit of normal
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular:
- •Left ventricular ejection fraction > 45%
- •DLCO ≥ 50% of predicted
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Recovered from prior stem cell transplantation
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent steroids
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供