Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer
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 recipient s 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.
To determine whether stem cell transplantation using low-dose chemotherapy and sirolimus-generated Th2 cells can cause a remission of advanced kidney cancer.
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.
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 (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 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., CT or MRI scans).
Renal Cell Carcinoma
Procedure: Allogeneic Hematopoietic Stem Cell Transplant
Procedure: Th2 Cell Transplantation
Drug: Th2 Cells in Allogeneic HSCT
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low Intensity Allogeneic Hematopoietic Stem Cell Transplantation Therapy of Metastatic Renal Cell Carcinoma Using Early and Multiple Donor Lymphocyte Infusions Consisting of Sirolimus-Generated Donor Th2 Cells|
- The primary outcome will be the frequency of subjects that achieve a partial remission of tumor (PR) or complete remission of tumor (CR). Tumor response will be measured by the RECIST criteria.
- (1) Immune depleting effect of pentostatin + cyclophosphamide; (2) Characterize the pattern of alloengraftment observed after this low-intensity transplant approach; (3) Evaluate any anti-tumor effector mechanism.
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923845
|Contact: Zetta A Blacklock-Schuver, R.N.||(301) email@example.com|
|Contact: Daniel H Fowler, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Daniel H Fowler, M.D.||National Cancer Institute (NCI)|