Leukemia Clinical Trial
Official title:
Phase II Study of 5-azacytidine and Lintuzumab in Myelodysplastic Syndromes (MDS)
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as lintuzumab, can block cancer growth in different ways. Some
block the ability of cancer cells to grow and spread. Others find cancer cells and help kill
them or carry cancer-killing substances to them. Giving chemotherapy together with
monoclonal antibodies may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying the side effects and how well giving azacitidine
together with lintuzumab works in treating patients with previously untreated
myelodysplastic syndromes.
OBJECTIVES:
Primary
- To determine the complete response rate of the combination of lintuzumab and
azacitidine in patients with myelodysplastic syndromes.
Secondary
- To define the specific toxicities of this regimen.
- To determine the overall response rate.
- To determine the relationship between pretreatment expression of Syk and clinical
response.
- To determine whether the investigational agents modulate Syk expression and to
correlate drug-induced changes in Syk with response to treatment.
- To provide preliminary data on the biological activity of azacitidine as a
demethylating agent (changes in target gene methylation and gene expression, DNMT1
protein expression, global methylation).
- To perform exploratory studies of azacitidine-triphosphate with global DNA methylation.
- To explore the biologic role of microRNA in determining clinical response to this
regimen and achievement of the other pharmacodynamic endpoints.
OUTLINE: Patients receive azacitidine IV or subcutaneously once daily on days 1-7 and
lintuzumab IV on days 2, 7, 15, and 22 (days 2 and 15 of course 1 only). Treatment repeats
every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment modifications may apply according to response.
Blood and bone marrow samples are collected periodically for pharmacodynamic studies.
After completion of study treatment, patients are followed up for 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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