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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Naoto Ueno, M.D., Ph.D.
United States: Institutional Review Board
|University of Minnesota||Minneapolis, Minnesota 55455|
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|M.D. Anderson Cancer Center||Houston, Texas 77030|
|University of California - Los Angeles||Los Angeles, California 90095|
|Shands - University of Florida||Gainesville, Florida 32610|