Status:
COMPLETED
Bortezomib in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
University of Rochester
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well bortezomib works in treating patien...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of bortezomib, in terms of reduced cytopenia, in patients with myelodysplastic syndromes. * Determine the safety and toxic effects of this drug in these ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00262873
Start Date
May 1 2005
End Date
October 1 2010
Last Update
May 9 2016
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642