NCT00015951CompletedPhase 2
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)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 3
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •No disseminated intravascular coagulation
- •AST/ALT no greater than 2 times normal
- •Alkaline phosphatase no greater than 2 times normal
- •Bilirubin no greater than 1.5 times normal
- •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)
- •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
- +8 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (3)
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