|
|
|
|
|
|
Sponsors and Collaborators: |
Oregon Health and Science University Cancer Institute National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00243009 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
Kidney Cancer |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Kidney Cancer |
ChemIDplus related topics: | Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 15 |
Study Start Date: | June 2005 |
OBJECTIVES:
OUTLINE:
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
United States, Oregon | |||||
Cancer Institute at Oregon Health and Science University | |||||
Portland, Oregon, United States, 97239-3098 |
Oregon Health and Science University Cancer Institute |
National Cancer Institute (NCI) |
Study Chair: | Brandon M. Hayes-Lattin, MD | Oregon Health and Science University |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000447207, OHSU-ONC-03077-L, OHSU-1282 |
First Received: | October 20, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00243009 |
Health Authority: | United States: Federal Government |
|
|
|
|
|