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Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer

2013年6月18日 更新者:National Cancer Institute (NCI)

Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer

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.

研究概览

详细说明

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.

Patients are followed twice weekly until day 100, and then at 6, 9, 12, 18, and 24 months.

PROJECTED ACCRUAL: A maximum of 70 patients will be accrued for this study within 24 months.

研究类型

介入性

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
      • Bethesda、Maryland、美国、20892
        • NCI - Center for Cancer Research

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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:

Age:

  • 18 to 70

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • More than 6 months

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin ≤ 2 mg/dL
  • SGOT < 4 times upper limit of normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal:

  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular:

  • Left ventricular ejection fraction > 45%

Pulmonary:

  • DLCO ≥ 50% of predicted

Other:

  • 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

Surgery:

  • Not specified

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 屏蔽:无(打开标签)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michael R. Bishop, MD、National Cancer Institute (NCI)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2000年6月1日

研究完成 (实际的)

2007年8月1日

研究注册日期

首次提交

2001年7月11日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (估计)

2013年6月20日

上次提交的符合 QC 标准的更新

2013年6月18日

最后验证

2004年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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