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Trial record 2 of 544 for:    stem cell kidney

Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318110
Recruitment Status : Terminated (Unable to meet subject enrollment goal.)
First Posted : April 26, 2006
Last Update Posted : July 26, 2016
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

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).

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Procedure: NST using MUD for metastatic renal cell carcinoma Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: MUD treatment
NST using MUD for metastatic renal cell carcinoma
Procedure: NST using MUD for metastatic renal cell carcinoma

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall survival after MUD NST [ Time Frame: Two years ]
  2. Rate of complete donor myeloid and lymphoid chimerism after MUD NST [ Time Frame: One year ]
  3. Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST [ Time Frame: Two years ]
  4. Incidence of treatment-related mortality (TRM) [ Time Frame: 100 Days ]
  5. Assess cytotoxic T-lymphocyte reactivity [ Time Frame: One year ]
  6. Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect [ Time Frame: Six months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318110

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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
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
M.D. Anderson Cancer Center
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Study Chair: Naoto Ueno, M.D., Ph.D. MDACC

Additional Information:
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Responsible Party: Center for International Blood and Marrow Transplant Research Identifier: NCT00318110    
Obsolete Identifiers: NCT00429130
Other Study ID Numbers: T00008
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only 2 subjects enrolled prior to study closure due to slow accrual.
Keywords provided by Center for International Blood and Marrow Transplant Research:
stage IV
clear cell
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases