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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004896 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Anemia Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Drug Information available for: | Cyclophosphamide Busulfan |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia |
| Study Start Date: | October 1999 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone marrow is infused on day 0.
Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow infusion on day 0.
All patients receive prophylaxis for graft versus host disease.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) acute myelogenous leukemia or myelodysplastic syndrome of 1 of the following subtypes:
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, Illinois | |||||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |||||
| Chicago, Illinois, United States, 60611 | |||||
| Robert H. Lurie Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Martin S. Tallman, MD | Robert H. Lurie Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067575, NU-91H4T, NCI-G00-1686 |
| First Received: | March 7, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004896 |
| Health Authority: | United States: Federal Government |
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