Leukemia Clinical Trial
Official title:
A Phase II Study of Bexarotene + Sargromastastin as Agents of Differentiation in MDS and AML
RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to
grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the
number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together
with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid
leukemia.
PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF
works in treating patients with MDS or acute myeloid leukemia.
OBJECTIVES:
Primary
- Assess the clinical response in patients with myelodysplastic syndromes or acute myeloid
leukemia treated with bexarotene and sargramostim (GM-CSF).
Secondary
- Determine the clinical activity of this regimen, in terms of transfusion requirements,
in these patients.
- Determine the biological activity of this regimen, in terms of biological markers and
cytogenetic abnormalities, in these patients.
- Assess the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive oral bexarotene and sargramostim (GM-CSF) subcutaneously on days
1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Blood and bone marrow samples are collected at baseline and after 1 or 2 courses of study
therapy. Samples are examined by flow cytometry for laboratory studies, including biological
markers, and by fluorescent in situ hybridization (FISH) for cytogenetic changes.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
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