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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354419 |
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects and best dose of total-body irradiation when given together with cyclophosphamide and antithymocyte globulin in treating patients with severe aplastic anemia undergoing umbilical cord blood transplant.
Condition | Intervention | Phase |
---|---|---|
Precancerous/Nonmalignant Condition |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: mycophenolate mofetil Procedure: total-body irradiation Procedure: umbilical cord blood transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a prospective, dose-finding study of total-body irradiation (TBI).
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | up to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of life-threatening marrow failure (severe aplastic anemia) of nonmalignant etiology meeting 2 of the following criteria:
Umbilical cord blood (UCB) donor available
If multiple units are selected, the following criteria apply:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Ann E. Woolfrey, MD 206-667-4453 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | Ann E. Woolfrey, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Ann E. Woolfrey ) |
Study ID Numbers: | CDR0000486613, FHCRC-2030.00 |
Study First Received: | July 19, 2006 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00354419 |
Health Authority: | Unspecified |
aplastic anemia |
Cyclosporine Precancerous Conditions Hematologic Diseases Clotrimazole Miconazole Tioconazole Anemia Cyclophosphamide |
Cyclosporins Antilymphocyte Serum Signs and Symptoms Anemia, Aplastic Mycophenolate mofetil Bone Marrow Diseases Aplastic anemia |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Antifungal Agents Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |