Status:
COMPLETED
Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, wor...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept. II. Determine the efficacy of 5-aza combined with etanercept in p...
Eligibility Criteria
Inclusion
- Int-2 or high risk MDS patients
- Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with:
- Single or multilineage cytopenia (absolute neutrophil count \[ANC\] \< 1500/μL, hemoglobin \[Hgb\],10g/dL, or platelet count \< 100,000/μL); or
- Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period
- Serum creatinine =\< 1.5x ULN (upper limit of normal)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2x ULN
- Performance status =\< 2 (Eastern Cooperative Oncology Group \[ECOG\] scale, 0-5)
Exclusion
- Patients who have previously received hematopoietic stem cell transplants, specifically for MDS
- Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e \>= 20% blasts) at time of enrollment
- Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
- Men who are unwilling to use contraception while receiving 5-aza
- Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol
- Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment
- Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS
- Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure
- Platelet count =\< 10,000/mcl
- Absolute neutrophil count =\< 250/mcl
- Prior treatment with 5-aza
- Known or suspected hypersensitivity to azacitidine or mannitol
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00118287
Start Date
April 1 2005
Last Update
May 24 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109