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Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

This study has been terminated.
(Unable to meet subject enrollment goal.)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00318110
First received: April 24, 2006
Last updated: July 25, 2016
Last verified: July 2016
April 24, 2006
July 25, 2016
April 2006
March 2009   (Final data collection date for 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 ]
Determine the best rate of tumor response of CR+CRU+PR within 6 months after MUD NST
Complete list of historical versions of study NCT00318110 on ClinicalTrials.gov Archive Site
  • Overall survival after MUD NST [ Time Frame: Two years ]
  • Rate of complete donor myeloid and lymphoid chimerism after MUD NST [ Time Frame: One year ]
  • Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST [ Time Frame: Two years ]
  • Incidence of treatment-related mortality (TRM) [ Time Frame: 100 Days ]
  • Assess cytotoxic T-lymphocyte reactivity [ Time Frame: One year ]
  • Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect [ Time Frame: Six months ]
  • Overall survival after MUD NST
  • Rate of complete donor myeloid and lymphoid chimerism after MUD NST
  • Incidence and severity of acute and chronic GvHD after MUD NST
  • Incidence of TRM
  • Assess cytotoxic T-lymphocyte reactivity
  • Assess antibodies activity against potential tumor antigenic peptides in graft-vs-RCC effect
Not Provided
Not Provided
 
Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma
Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma
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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Experimental: MUD treatment
NST using MUD for metastatic renal cell carcinoma
Intervention: Procedure: NST using MUD for metastatic renal cell carcinoma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00318110
T00008
Yes
Not Provided
Plan to Share IPD: No
Plan Description: Only 2 subjects enrolled prior to study closure due to slow accrual.
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
M.D. Anderson Cancer Center
Study Chair: Naoto Ueno, M.D., Ph.D. MDACC
Center for International Blood and Marrow Transplant Research
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP