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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027820 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Drugs such as mycophenolate mofetil and cyclosporine may prevent this from happening.
PURPOSE: Phase I/II trial to study the effectiveness of total-body irradiation and chemotherapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer or kidney cancer.
| Condition | Intervention | Phase |
|
Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
| Drug Information available for: | Fludarabine Fludarabine monophosphate Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-Center Trial |
| Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed weekly until day 90, at 4, 6, 12, 18, and 24 months, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 150 patients will be accrued for this study within 2 years.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic renal cell carcinoma not amenable to surgical cure
Histologically proven hematologic malignancy including, but not limited to, the following:
Intermediate or high-grade non-Hodgkin's lymphoma (NHL)
Low-grade NHL
Chronic lymphocytic leukemia
Hodgkin's lymphoma
Multiple myeloma
Acute myeloid leukemia (AML)
Acute lymphoblastic leukemia
Chronic myelogenous leukemia (CML)
Myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD)
Over age 50:
Age 50 and under:
Availability of unrelated donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |||||
| City of Hope Comprehensive Cancer Center | |||||
| Duarte, California, United States, 91010-3000 | |||||
| Stanford University Medical Center | |||||
| Stanford, California, United States, 94305-5623 | |||||
| Stanford University | |||||
| Stanford, California, United States, 94305 | |||||
| United States, Colorado | |||||
| University of Colorado Cancer Center | |||||
| Denver, Colorado, United States, 80010 | |||||
| United States, Georgia | |||||
| Emory University School of Medicine | |||||
| Atlanta, Georgia, United States, 30322 | |||||
| United States, Oregon | |||||
| Oregon Cancer Institute | |||||
| Portland, Oregon, United States, 97239 | |||||
| United States, Texas | |||||
| Baylor University Medical Center | |||||
| Dallas, Texas, United States, 75246 | |||||
| United States, Utah | |||||
| Huntsman Cancer Institute | |||||
| Salt Lake City, Utah, United States, 84112 | |||||
| United States, Washington | |||||
| Fred Hutchinson Cancer Research Center | |||||
| Seattle, Washington, United States, 98109-1024 | |||||
| United States, Wisconsin | |||||
| Medical College of Wisconsin Cancer Center | |||||
| Milwaukee, Wisconsin, United States, 53226 | |||||
| Germany | |||||
| Universitaet Leipzig | |||||
| Leipzig, Germany, D-04103 | |||||
| Italy | |||||
| University of Torino | |||||
| Torino, Italy, 10126 | |||||
| Fred Hutchinson Cancer Research Center |
| National Cancer Institute (NCI) |
| Study Chair: | Michael B. Maris, MD | Fred Hutchinson Cancer Research Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069076, FHCRC-1641.00, NCI-H01-0081 |
| First Received: | December 7, 2001 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00027820 |
| Health Authority: | United States: Federal Government |
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