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Sponsored by: |
Fred Hutchinson Cancer Research Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00119366 |
RATIONALE: Giving chemotherapy drugs, such as fludarabine, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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 fludarabine and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute myeloid leukemia or myelodysplastic syndromes.
PURPOSE: This phase I/II trial is studying the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients for advanced acute myeloid leukemia or myelodysplastic syndromes.
Condition | Intervention | Phase |
Leukemia Myelodysplastic Syndromes |
Drug: cyclosporine Drug: fludarabine phosphate Drug: iodine I 131 monoclonal antibody BC8 Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I Phase II |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
ChemIDplus related topics: | Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin Iodine Cadexomer iodine Sodium iodide I 131 Mycophenolate Mofetil Mycophenolate mofetil hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Feasibility Trial Combining Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine and Low Dose TBI Followed by Related or Unrelated PBSC Infusion and Post-Transplant Immunosuppression for Patients With Advanced AML or High Risk Myelodysplastic Syndrome |
Estimated Enrollment: | 30 |
Study Start Date: | May 2003 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of therapeutic dose iodine I 131 monoclonal antibody BC8 (^131I MOAB BC8).
Cohorts of 1-4 patients receive escalating therapeutic doses of ^131I MOAB BC8 until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience graft failure.
Treatment continues in the absence of unacceptable toxicity or development of anti-mouse antibodies.
After completion of study treatment, patients are followed at 6, 9, and 12 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study.
Ages Eligible for Study: | 16 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following diseases
Myelodysplastic syndromes (MDS), expressed as 1 of the following:
Advanced acute myeloid leukemia beyond first remission, primary refractory disease, OR evolved from MDS or myeloproliferative disorders
Meets 1 of the following criteria:
Not in first remission AND has CD45-expressing leukemic blasts
In remission
Peripheral blood stem cell donor available, meeting 1 of the following criteria:
HLA-matched identical sibling donor
HLA-matched unrelated donor
Matched for HLA-A, -B, -C, -DRB1, and -DQB1 at the allele level
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Washington | |||||
Fred Hutchinson Cancer Research Center | Recruiting | ||||
Seattle, Washington, United States, 98109-1024 | |||||
Contact: John Pagel, MD, PhD 206-667-1868 | |||||
Pacific Northwest National Laboratory | Recruiting | ||||
Richland, Washington, United States, 99352 | |||||
Contact: D.R. Fisher, PhD 888-375-7665 | |||||
Seattle Cancer Care Alliance | Recruiting | ||||
Seattle, Washington, United States, 98109-1023 | |||||
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |||||
Veterans Affairs Medical Center - Seattle | Recruiting | ||||
Seattle, Washington, United States, 98108 | |||||
Contact: Thomas R. Chauncey, MD, PhD 206-764-2199 |
Fred Hutchinson Cancer Research Center |
Principal Investigator: | John Pagel, MD, PhD | Fred Hutchinson Cancer Research Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000430691, FHCRC-1809.00 |
First Received: | July 12, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00119366 |
Health Authority: | Unspecified |
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