Bevacizumab in Treating Patients With Myelodysplastic Syndrome
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Stanford Cancer Center at Stanford University Medical Center
- University of Texas - MD Anderson Cancer Center