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Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

Phase 2
18 Years
65 Years
Not Enrolling
Metastatic Renal Cell Carcinoma

Thank you

Trial Information

Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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)

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Naoto Ueno, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

January 2009

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Metastatic
  • Renal
  • Cell
  • Carcinoma
  • Unrelated
  • Donor
  • Transplant
  • stage IV
  • clear cell
  • Carcinoma
  • Carcinoma, Renal Cell



University of MinnesotaMinneapolis, Minnesota  55455
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
M.D. Anderson Cancer CenterHouston, Texas  77030
University of California - Los AngelesLos Angeles, California  90095
Shands - University of FloridaGainesville, Florida  32610