A Phase II Study of Bexarotene + Sargromastastin as Agents of Differentiation in MDS and AML
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Clinical Response (Complete and Partial)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: fluorescence in situ hybridization (Genetic)
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: sargramostim (Biological)
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: bexarotene (Drug)
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: cytogenetic analysis (Genetic)
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: flow cytometry (Other)
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: laboratory biomarker analysis (Other)
Bexarotene + GM-CSF
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
干预措施: biopsy (Procedure)
结局指标
主要结局
Clinical Response (Complete and Partial)
时间窗: assessed after 2 cycles, up to 2 years
Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria.
次要结局
- Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements(Baseline and after two cycles)
- Biological Activity as Measured by in Vivo Induction of Terminal Differentiation of Myeloid Progenitors and in Vivo Changes in Detectable Chromosomal Abnormalities(Baseline and 6, 12, 24, and 36 weeks)