NCT00301730已完成1 期
Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for breast cancer that has spread to the lung.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor response in a patient with persistent metastatic breast cancer after prior allogeneic hematopoietic stem cell transplantation (SCT) treated with tumor-derived, ex vivo expanded and costimulated T-lymphocytes.
Secondary
- Evaluate the immune function of tumor-derived T-lymphocytes and the biology of residual tumor cells present after allogeneic hematopoietic SCT.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage IIB HER2/neu-expressing breast cancer 6½ years ago
- •Received a T-cell-depleted allogeneic stem cell transplantation (SCT) from a 6/6 HLA-matched sibling donor for refractory metastatic breast cancer
- •Developed pulmonary metastases during adjuvant chemotherapy following modified radical mastectomy
- •Pulmonary metastases progressed after prior allogeneic SCT
- •Responded in an objective and measurable manner to prior allogeneic lymphocyte infusion, post-transplantation chemotherapy, and trastuzumab (Herceptin®)
- •Disease limited to the thoracic cavity
- •Operable tumor with at least 1 cm of surgically accessible lesion
- •Preoperative risk assessment indicating ≤ 5% risk of mortality and < 15% risk of significant morbidity for pulmonary metastasectomy
- •Enrolled on protocol CC# 00-C-0119
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Life expectancy > 6 months
- •Negative pregnancy test
- •Adequate pulmonary reserve
- •Prior graft-versus-host disease (GVHD) ≤ grade 1
- •No concurrent GVHD
- •No active infection nonresponsive to antimicrobial therapy
- •No active psychiatric disorder that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 4 weeks since prior systemic immunosuppressive therapy
- •At least 2 weeks since prior cytotoxic therapy and immunotherapy (e.g. trastuzumab [Herceptin®])
- •No concurrent immunosuppressive therapy
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00331526Hoag Memorial Hospital Presbyterian83
已完成
1 期
Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2Brain Stem GliomaAnaplastic AstrocytomaAnaplastic MeningiomaGiant Cell GlioblastomaAnaplastic EpendymomaAnaplastic OligodendrogliomaEpendymoblastomaGliosarcomaGrade III MeningiomaMixed GliomaMeningeal HemangiopericytomaPineal Gland AstrocytomaBrain TumorGlioblastomaNCT01082926City of Hope Medical Center6
已完成
1 期
Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Stage IV MelanomaRecurrent MelanomaStage IV MelanomaNCT00438984Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium11
Unknown
1 期
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid TumorsNasopharyngeal CarcinomaBreast CarcinomaHepatocellular CarcinomaNCT01462903Sun Yat-sen University20
已完成
1 期
Cellular Adoptive Immunotherapy in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes That Relapsed After Donor Stem Cell TransplantMyelodysplastic SyndromesLeukemiaNCT00107354Fred Hutchinson Cancer Center