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| Tracking Information | |||||
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| First Received Date ICMJE | April 24, 2006 | ||||
| Last Updated Date | September 29, 2008 | ||||
| Start Date ICMJE | April 2006 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Determine the best rate of tumor response of CR+CRU+PR within 6 months after MUD NST | ||||
| Change History | Complete list of historical versions of study NCT00318110 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Metastatic Renal Cell Carcinoma | ||||
| Intervention ICMJE | Procedure: NST using MUD for metastatic renal cell carcinoma | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 4 | ||||
| Estimated Completion Date | January 2009 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00318110 | ||||
| Responsible Party | Roberta King, MPH VP of CIBMTR, National Marrow Donor Program | ||||
| Study ID Numbers ICMJE | T00008 | ||||
| Study Sponsor ICMJE | Center for International Blood and Marrow Transplant Research | ||||
| Collaborators ICMJE | M.D. Anderson Cancer Center | ||||
| Investigators ICMJE |
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| Information Provided By | Center for International Blood and Marrow Transplant Research | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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