Bevacizumab in Treating Patients With Myelodysplastic Syndrome

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.

Detailed Description
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OBJECTIVES: Determine the hematologic responses, including changes in hemoglobin levels, neutrophil counts, platelet counts, and percentage of bone marrow blasts, in patients with myelodysplastic syndrome treated with bevacizumab. Determine the toxic effects of this regimen in these patients. Determine the tolerance in patients treated with this regimen. Determine bone marrow cytogenetic responses in patients treated with this regimen. Determine bone marrow microvessel density in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to International Prognostic Scoring System risk status (low (low or intermediate-1) vs high (intermediate-2 or high)). Patients receive bevacizumab IV over 30-90 minutes. Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at weeks 1, 3, 5, 7, and 9. PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 2 years.

Official Title
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Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)

Conditions
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Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Intervention / Treatment
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* Biological: bevacizumab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed myelodysplastic syndrome (MDS) Refractory anemia (RA) RA with excess blasts (RAEB) RAEB in transformation RA with ringed sideroblasts Non-proliferative chronic myelomonocytic leukemia (WBC less than 12,000/mm^3) At least 1 of the following cytopenias: Untransfused hemoglobin no greater than 10.0 g/dL and/or red cell transfusion dependent Absolute neutrophil count no greater than 1,800/mm^3 (neutropenia) Platelet count no greater than 100,000/mm^3 (thrombocytopenia) No secondary MDS No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: More than 4 months Hematopoietic: See Disease Characteristics Platelet count at least 20,000/mm^3 No hemorrhagic illness within the past 3 weeks No hemolysis No iron deficiency No active blood loss Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.0 mg/dL INR less than 2.0 PTT less than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL No renal dysfunction requiring dialysis within the past 6 months No nephrotic syndrome within the past 6 months Cardiovascular: No myocardial infraction within the past 6 months No severe or unstable angina within the past 6 months No severe peripheral vascular disease (ischemic rest pain, non-healing wound or ulcer, or tissue loss) within the past 6 months No uncontrolled hypertension within the past 6 months No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No deep venous or arterial thrombosis No coronary artery disease No symptomatic congestive heart failure (New York Heart Association class II-IV heart disease) No cardiac arrhythmia No vascular illness within the past 3 weeks Pulmonary: No pulmonary embolism Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other active malignancy except localized squamous cell or basal cell skin cancer Prior cured malignancy allowed No trauma within the past 3 weeks No significant inflammatory disease within the past 3 weeks No serious non-healing wound, ulcer, or bone fracture No hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies No other active severe disease No infection No psychiatric illness or social situation that would preclude study compliance HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic bone marrow transplantation At least 30 days since prior biologic response modifiers At least 30 days since prior hematopoietic growth factors At least 30 days since prior thalidomide No concurrent thalidomide No other concurrent biologic response modifiers No concurrent hematopoietic growth factors (including epoetin alfa) Concurrent filgrastim (G-CSF) for febrile neutropenia allowed Concurrent transfusions allowed Chemotherapy: At least 30 days since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroid therapy (more than 10 mg/day of prednisone or equivalent steroid dose) except for pre-medication for transfusions Radiotherapy: At least 30 days since prior radiotherapy No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery (including biopsy of visceral organ) Other: At least 10 days since prior anticoagulants No concurrent cytotoxic agents No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bevacizumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, atypical chronic myeloid leukemia, BCR-ABL1 negative