Spots Global Cancer Trial Database for Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers

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Trial Identification

Brief Title: Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers

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 ID: NCT00015951

Conditions

Leukemia

Myelodysplastic Syndromes

Interventions

bevacizumab

cytarabine

mitoxantrone hydrochloride

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.