Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers

University of Maryland, Baltimore

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Leukemia Myelodysplastic Syndromes

Interventions

bevacizumabBIOLOGICAL

cytarabineDRUG

mitoxantrone hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed poor-risk hematologic malignancy * Relapsed or refractory acute myelogenous leukemia (AML) * Primary induction failure * Myelodysplasia(MDS)-related AML * Secondary AML * Relapsed or refractory MDS * Primary induction failure * Refractory anemia with excess blasts (RAEB) * RAEB in transformation * Chronic myelomonocytic leukemia * Chronic myelogenous leukemia in blast crisis * Failure of prior primary induction therapy or relapse after achieving complete remission allowed only if no more than 3 courses of prior induction/reinduction therapy were received * No hyperleukocytosis (50,000 or more leukemic blasts/mm3) * No active CNS leukemia PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * No disseminated intravascular coagulation Hepatic: * AST/ALT no greater than 2 times normal * Alkaline phosphatase no greater than 2 times normal * Bilirubin no greater than 1.5 times normal Renal: * Creatinine no greater than 1.5 times normal Cardiovascular: * LVEF at least 45% by MUGA or echocardiogram * No myocardial infarction within the past 3 months * No history of severe coronary artery disease * No cardiomyopathy * No New York Heart Association class III or IV heart disease (congestive heart failure) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active uncontrolled infection * No history of cytarabine-related neurotoxicity * No evidence of graft-versus-host disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior hematopoietic growth factors including epoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF) * At least 1 week since prior interleukin-3 or interleukin-11 * At least 4 weeks since prior autologous stem cell transplantation * At least 90 days since prior allogeneic stem cell transplantation * No other concurrent immunotherapy Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered * No prior cytarabine administered as a 72-hour continuous infusion followed by mitoxantrone IV over 30 minutes * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * At least 2 weeks since prior immunosuppressive therapy * No other concurrent investigational or commercially available antitumor therapy

Locations (3)

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.