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)
- 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
Primary Purpose: Treatment
Judith E. Karp, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Marlene and Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201-1595|
|Blood and Marrow Transplant Group of Georgia||Atlanta, Georgia 30342-1601|