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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00005940 |
Purpose
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy and bone marrow transplantation in treating patients who have acute myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: busulfan Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Radiation: iodine I 131 monoclonal antibody BC8 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Study of Radiolabled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-identical Related Marrow Transplantation |
| Study Start Date: | October 1999 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive a test dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB BC8) IV, then about 2 weeks later, on day -13, a therapeutic dose of I131 MOAB BC8 IV is administered. Patients then receive oral busulfan every 6 hours on days -7 to -4 (16 doses) and cyclophosphamide IV on days -3 and -2. Donor bone marrow is infused on day 0.
Patients are followed at 6, 9, and 12 months, then every 6 months for 1 year, then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 16 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | John Pagel, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00005940 History of Changes |
| Other Study ID Numbers: | 1470.00, FHCRC-1470.00, NCI-H00-0056, CDR0000067778 |
| Study First Received: | July 5, 2000 |
| Last Updated: | August 20, 2010 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
|
adult acute myeloid leukemia in remission |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Antibodies Immunoglobulins Antibodies, Monoclonal Busulfan Cyclophosphamide Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents |