Bortezomib in Treating Patients With Myelodysplastic Syndromes
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring previously treated myelodysplastic syndromes, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, secondary myelodysplastic syndromes, de novo myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of myelodysplastic syndromes (MDS) Requires treatment or transfusion support for MDS, as indicated by 1 of the following: Demonstrates transfusion or epoetin alfa dependence Transfusion dependence is defined as requiring ≥ 2 units of packed RBCs within an 8-week period prior to study entry Hemoglobin < 11g/dL on 2 separate occasions 2 weeks apart No iron, cyanocobalamin (vitamin B_12), or folic acid deficiency or other causes of anemia Must have 1 of the following FAB subtypes: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Secondary MDS (if ≥ 3 years since active primary cancer) No chronic myelomonocytic leukemia Not refractory to platelet transfusion support (i.e., inability to maintain platelet count > 20,000/mm^3 with transfusion) No current acute myelogenous leukemia (e.g., > 30% blasts) PATIENT CHARACTERISTICS: Performance status Karnofsky 50-100% Life expectancy At least 6 months Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 2 mg/dL AST and ALT < 2 times upper limit of normal Renal Creatinine clearance ≥ 30 mL/min Cardiovascular No significant cardiovascular condition that would preclude study participation No uncontrolled hypertension Pulmonary No significant pulmonary condition that would preclude study participation Immunologic No serious concurrent infection Active infections must be adequately treated with antibiotics prior to study entry No hypersensitivity to bortezomib, boron, or mannitol Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 4 weeks after completion of study treatment No peripheral neuropathy ≥ grade 2 No uncontrolled seizure activity, as defined by no activity within the past year on stable anticonvulsant medications No other malignancy within the past 3 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No endocrine, neurologic, or other systemic disease that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior allogeneic bone marrow transplantation Concurrent transfusion support allowed Concurrent epoetin alfa or darbepoetin alfa allowed if initiated before start of study therapy, dose is stable for ≥ 4 weeks, and dose is stable during study participation No concurrent platelet growth factor support No concurrent thalidomide Chemotherapy No concurrent chemotherapy No concurrent hydroxyurea Endocrine therapy Concurrent corticosteroids for chronic autoimmune or inflammatory condition allowed if initiated before start of study therapy and maintained on a stable or decreasing dose Other Recovered from all prior therapies At least 4 weeks since prior MDS therapy, except epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), pegfilgrastim (G-CSF), or transfusion support At least 30 days since prior investigational agents No prior bortezomib No other concurrent investigational agents No other concurrent therapy for MDS
Sites / Locations
- James P. Wilmot Cancer Center at University of Rochester Medical Center
Arms of the Study
Arm 1
Experimental
Bortezomib