Status:
TERMINATED
Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulati...
Detailed Description
OBJECTIVES: Primary * Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine, darbepoetin alfa, and filgrastim (G-CSF). Secondary * Determine...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndromes (MDS)
- Bone marrow aspirate and biopsy with karyotyping performed within the past 8 weeks
- Patients with chronic myelomonocytic leukemia (CMML), refractory anemia (RA), or refractory anemia with ringed sideroblasts (RARS) according to FAB classification OR RA, RARS, refractory anemia with multilineage dysplasia, or RARS with multilineage dysplasia according to WHO classification must meet ≥ 1 of the following criteria:
- Symptomatic anemia requiring RBC transfusion for ≥ 3 months before study entry
- Thrombocytopenia with ≥ 2 platelet counts \< 50,000/mm³ OR a significant hemorrhage requiring platelet transfusion
- Neutropenia with an absolute neutrophil count \< 1,000/mm³ and an infection requiring IV antibiotics
- No refractory anemia with excess blasts in transformation
- No history of leukemia
- No known primary or metastatic hepatic tumor
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 2 months
- AST and ALT ≤ 2 times upper limit of normal
- Creatinine \< 2.0 mg/dL
- Serum vitamin B12 normal
- Serum and/or red cell folate levels normal
- Ferritin ≥ 50 ng/mL
- Copper \> 40 µg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- PRIOR CONCURRENT THERAPY:
- No prior azacitidine or decitabine
- No prior therapy for MDS
- Supportive therapy within the past 28 days allowed
- No other concurrent treatment for MDS (i.e., thalidomide, arsenic trioxide, cyclosporine, or melphalan)
- No other concurrent hematopoietic growth factors, including epoetin alfa, filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11 (oprelvekin)
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00398047
Start Date
September 1 2006
End Date
September 1 2009
Last Update
September 6 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096