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临床试验/NCT00318110
NCT00318110终止2 期

Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

Center for International Blood and Marrow Transplant Research10 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
4
试验地点
10
主要终点
Determine the best rate of tumor response of complete response (CR) + complete unconfirmed response (CRU) + partial response (PR) within 6 months after matched unrelated donor (MUD) nonmyeloablative stem cell transplantation (NST)

研究概览

简要总结

The purpose of this study is to find out what effects (good and bad) a stem cell transplant from an unrelated donor will have for patients with kidney cancer that has spread to other parts of the body (metastasized).

详细描述

Standard treatment for kidney cancer that has spread to other parts of the body may include immunotherapy (a therapy that uses the body's natural immune system to fight cancer) and cytokines (proteins found in the body). If these treatments are not successful at controlling the cancer then chemotherapy or thalidomide are used. Chemotherapy and thalidomide will not cure kidney cancer but they may control the disease in some patients.

In some patients, transplants are now proposed for study. Stem cells (from bone marrow or the bloodstream) are normally used to treat cancers of the blood, not kidney cancer. Since researchers are still learning about using stem cell transplants for kidney cancer, the study is considered a research study. Patients participating in this study will receive smaller doses of chemotherapy drugs to prepare them for the transplant than patients who have a standard transplant. This type of transplant is called a "reduced intensity" transplant. A reduced intensity transplant uses the cell-killing activity of the transplanted donor stem cells to attack the recipient's cancer cells. This is called graft-versus-tumor-effect (GVT). Previous studies have shown that GVT may be greater if the donor is not related to the recipient.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of metastatic (stage IV) renal cell carcinoma (RCC) predominately clear cell type
  • Prior nephrectomy
  • Available HLA-matched (8/8, 7/8) unrelated donor
  • At least one prior immunotherapy; or immunotherapy + chemotherapy; or targeted therapy, for metastatic RCC.
  • Adequate organ function

排除标准

  • Prior allogeneic stem cell transplantation
  • RCC with histology other than clear cell type
  • History or presence of brain metastasis

结局指标

主要结局

Determine the best rate of tumor response of complete response (CR) + complete unconfirmed response (CRU) + partial response (PR) within 6 months after matched unrelated donor (MUD) nonmyeloablative stem cell transplantation (NST)

时间窗: 6 months

次要结局

  • Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST(Two years)
  • Overall survival after MUD NST(Two years)
  • Rate of complete donor myeloid and lymphoid chimerism after MUD NST(One year)
  • Assess cytotoxic T-lymphocyte reactivity(One year)
  • Incidence of treatment-related mortality (TRM)(100 Days)
  • Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect(Six months)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (10)

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