Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer
Status:
Completed
Trial end date:
2017-06-22
Target enrollment:
Participant gender:
Summary
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).