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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 |
Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I Phase II |
| 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
However, this protocol uses the former terminology.
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 | |
| Study Chair: | Michael B. Maris, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000069076, FHCRC-1641.00, NCI-H01-0081 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027820 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult Hodgkin lymphoma refractory multiple myeloma stage IV renal cell cancer recurrent renal cell cancer relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission clear cell renal cell carcinoma recurrent/refractory childhood Hodgkin lymphoma refractory anemia |
refractory anemia with ringed sideroblasts stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III adult diffuse large cell lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV adult diffuse large cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent adult diffuse large cell lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma |
|
Cyclosporine Urogenital Neoplasms Mantle Cell Lymphoma Cyclosporins Refractory Anemia Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Thrombocythemia, Hemorrhagic Kidney Diseases Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders |
Leukemia, Myeloid Carcinoma Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Precancerous Conditions Immunologic Factors Blood Protein Disorders Lymphoma, Follicular Lymphoblastic Lymphoma Lymphoma, B-Cell Leukemia Urologic Diseases |
|
Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Cyclosporins Preleukemia Neoplasms by Site Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Mycophenolate mofetil Cardiovascular Diseases |
Kidney Diseases Dermatologic Agents Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Carcinoma Multiple Myeloma Neoplasms Fludarabine Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Antimetabolites Precancerous Conditions Immunologic Factors |