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| Sponsor: | Center for International Blood and Marrow Transplant Research |
|---|---|
| Collaborator: |
M.D. Anderson Cancer Center |
| Information provided by: | Center for International Blood and Marrow Transplant Research |
| ClinicalTrials.gov Identifier: | NCT00318110 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Renal Cell Carcinoma |
Procedure: NST using MUD for metastatic renal cell carcinoma |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma |
| Enrollment: | 4 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Preparative regimen:
Fludarabine 25 mg/m2 IV once a day x 5 days (-6,-5,-4,-3,-2) Melphalan 70 mg/m2 IV once a day x 2 days (-3,-2) Donor Stem Cell Infusion: Stem cells will be infused on day 0 GVHD prophylaxis: Tacrolimus and methotrexate 5 mg/m2 IV day 1, 3, 6 and 11
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California - Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Shands - University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Naoto Ueno, M.D., Ph.D. | MDACC |
More Information
| Responsible Party: | Roberta King, MPH VP of CIBMTR, National Marrow Donor Program |
| ClinicalTrials.gov Identifier: | NCT00318110 History of Changes |
| Obsolete Identifiers: | NCT00429130 |
| Other Study ID Numbers: | T00008 |
| Study First Received: | April 24, 2006 |
| Last Updated: | September 29, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Metastatic Renal Cell Carcinoma Unrelated |
Donor Transplant stage IV clear cell |
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |