Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00015951|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2009
RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer.
PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Biological: bevacizumab Drug: cytarabine Drug: mitoxantrone hydrochloride||Phase 2|
- Determine the clinical effectiveness of bevacizumab, cytarabine, and mitoxantrone in patients with poor-risk hematologic malignancies.
- Determine the toxic effects of this regimen in these patients.
- Determine whether this regimen can induce cell apoptosis in these patients.
- Determine the effects of bevacizumab on coagulation profiles in these patients.
OUTLINE: This is a multicenter study.
Patients receive cytarabine IV continuously over 72 hours on days 1-3, mitoxantrone IV over 30-60 minutes on day 4, and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-45 patients will be accrued for this study within 1-3 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of the Recombinant Human Monoclonal Anti-Vascular Endothelial Growth Factor Antibody (rhuMAB VEGF) Bevacizumab (NSC #704865, IND # 7,921) Administered in Times Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs)|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||March 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015951
|United States, Georgia|
|Blood and Marrow Transplant Group of Georgia|
|Atlanta, Georgia, United States, 30342-1601|
|United States, Maryland|
|Marlene and Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Judith E. Karp, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|