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Unable to meet subject enrollment goal.
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MUD treatment | Experimental | NST using MUD for metastatic renal cell carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NST using MUD for metastatic renal cell carcinoma | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival after MUD NST | Two years | |
| Rate of complete donor myeloid and lymphoid chimerism after MUD NST | One year | |
| Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naoto Ueno, M.D., Ph.D. | MDACC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Los Angeles | Los Angeles | California | 90095 | United States | ||
| Shands - University of Florida |
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| Label | URL |
|---|---|
| Click for more information about the Center for International Blood and Marrow Transplant Research | View source |
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Only 2 subjects enrolled prior to study closure due to slow accrual.
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Two years |
| Incidence of treatment-related mortality (TRM) | 100 Days |
| Assess cytotoxic T-lymphocyte reactivity | One year |
| Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect | Six months |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |