Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma, Graft-Versus-Host Disease, Engraftment Syndrome

In brief

Background: Low-dose chemotherapy is easier for the body to tolerate than typical high-dose chemotherapy and involves a shorter period of complete immune suppression. Donor immune cells called lymphocytes, or T cells, fight residual tumor cells that might have remained in the recipients body after stem cell transplant, in what is called a graft-versus-tumor (GVT) effect. The immune-suppressing drug sirolimus appears to help prevent graft-versus-host disease (GVHD), a side effect of stem cell transplant in which donated T cells sometimes attack healthy tissues, damaging organs such as the liver, intestines and skin. Th2 cells are cells collected from the transplant donor and grown in a high concentration of sirolimus. Objectives: To determine whether stem cell transplantation using low-dose chemotherapy and sirolimus-generated Th2 cells can cause a remission of advanced kidney cancer. Eligibility: Patients between 18 and 75 years of age who have kidney cancer that has spread beyond the kidney and who have a tissue-matched sibling stem cell donor. Design: Patients undergo stem cell transplantation as follows: * Low-intensity chemotherapy with pentostatin and cyclophosphamide over a 21-day period to reduce the level of the immune system to prepare for the transplant. Pentostatin is given through a vein (intravenous (IV)) on days 1, 8 and 15; cyclophosphamide tablets are taken by mouth for 21 consecutive days. * Sirolimus tablets, taken by mouth, starting 2 days before the transplant and continuing until 60 days after the transplant. * IV infusions of stem cells and Th2 cells. Following the transplant, patients have the following procedures: * Additional Th2 cell infusions on days 14 and 45 after the transplant. * Follow-up visits at the National Institutes of Health (NIH) Clinical Center twice a week for the first 6 months after the transplant and then less frequently for at least 5 years to evaluate response to treatment and treatment side effects. Evaluations include a bone marrow aspirate and biopsy 1 month after transplant and periodic blood tests and imaging procedures (e.g., computed tomography (CT) or magnetic resonance imaging (MRI) scans).

Key facts

Study ID
NCT00923845
Run by
National Cancer Institute (NCI)
People needed
25
Starts
2008-03-01
Expected to finish
2017-06-22
Last updated by the study team
2017-09-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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