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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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
University of California - Los Angeles
Los Angeles, California, United States
Shands - University of Florida
Gainesville, Florida, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
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
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
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M.D. Anderson Cancer Center
Houston, Texas, United States