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| Descriptive Information Fields | |||||
| Brief Title † | Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma | ||||
| Official Title † | Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma | ||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Overall survival after MUD NST [ Time Frame: Two years ] [ Designated as safety issue: Yes ] Rate of complete donor myeloid and lymphoid chimerism after MUD NST [ Time Frame: One year ] [ Designated as safety issue: Yes ] Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST [ Time Frame: Two years ] [ Designated as safety issue: Yes ] Incidence of treatment-related mortality (TRM) [ Time Frame: 100 Days ] [ Designated as safety issue: Yes ] Assess cytotoxic T-lymphocyte reactivity [ Time Frame: One year ] [ Designated as safety issue: Yes ] Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect [ Time Frame: Six months ] [ Designated as safety issue: Yes ] |
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| Condition † | Metastatic Renal Cell Carcinoma | ||||
| Intervention † | Procedure: NST using MUD for metastatic renal cell carcinoma | ||||
| MEDLINE PMIDs | |||||
| Links | Click for more information about the Center for International Blood and Marrow Transplant Research  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 50 | ||||
| Start Date † | April 2006 | ||||
| Completion Date | January 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00318110 | ||||
| Organization ID | T00008 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Center for International Blood and Marrow Transplant Research | ||||
| Collaborators †† | M.D. Anderson Cancer Center | ||||
| Investigators † |
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| Information Provided By | Center for International Blood and Marrow Transplant Research | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 24, 2006 | ||||
| Last Updated Date | April 8, 2008 | ||||
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