A Pilot Study of Phenylbutyrate, Dexamethasone and GM-CSF in Refractory or Relapsed t(8;21) Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 7
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining phenylbutyrate, dexamethasone, and sargramostim in treating patients who have refractory or relapsed acute myeloid leukemia.
详细描述
OBJECTIVES:
- Determine the objective response (complete hematologic remission induction) of phenylbutyrate, dexamethasone, and sargramostim (GM-CSF) in patients with refractory or relapsed t(8;21) acute myeloid leukemia.
- Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with response rate in patients treated with this regimen.
- Determine the overall survival of patients on this regimen.
- Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with pharmacokinetics of this regimen in these patients.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive phenylbutyrate IV continuously and sargramostim (GM-CSF) subcutaneously on days 1-7 and 15-21. Patients also receive oral dexamethasone on days 1-4 and 15-18. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity until complete hematologic remission is induced. Patients with stable disease at the end of 1 course receive at least 2 additional courses.
Patients are followed twice a week for 3 months, monthly for 1 year, every three months for the next 4 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of t(8;21) acute myeloid leukemia (AML)
- •Failed standard induction chemotherapy or stem cell transplantation (SCT) OR
- •Relapsed after standard induction chemotherapy or SCT OR
- •Refused or not a candidate for SCT or matched allogeneic sibling bone marrow transplantation or donor lymphocyte infusion OR
- •Refused of not a candidate for autologous SCT or bone marrow transplantation
- •No CNS leukemia
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 7 days
- •Hematopoietic:
- •Not specified
- •AST or ALT no greater than 3 times upper limit of normal (ULN)
- •Bilirubin no greater than 3 times ULN
- •No hepatic disease that would preclude study
- •Creatinine no greater than 2 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No renal disease that would preclude study
- •Cardiovascular:
- •No cardiac disease that would preclude study
- •No New York Heart Association class III or IV heart disease
- •No myocardial infarction within past 8 weeks
- •No active infection except cystitis
- •Not pregnant or nursing
- •No altered mental status or seizure disorder
- •No other serious disease that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •At least 3 weeks since prior investigational antineoplastic drugs
排除标准
- 未提供