NCT00042822已完成2 期
A Pilot Study Of FR901228, Or Depsipeptide (NSC #630176) For Adult Patients With Advanced Hematologic Cancers
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
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.
PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome, acute myeloid leukemia, or intermediate-grade or follicular non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).
- Determine the disease response in patients treated with this drug.
- Determine the pharmacokinetic and pharmacodynamic correlates of this drug, including measurement of serum plasma levels, H3 and H4 acetylation, apoptosis induction, differentiation, and multidrug-resistant (MDR) phenotype expression in these patients.
OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.
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
- •Refractory anemia with excess blasts (RAEB)
- •RAEB in transformation
- •Chronic myelomonocytic leukemia
- •Ineligible for or refused allogeneic bone marrow transplantation
- •Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL)
- •Relapsed after high-dose therapy OR
- •Ineligible for allogeneic or autologous stem cell transplantation
- •Evaluable lesions by radiologic study or physical examination
- •Histologically confirmed follicular NHL
- •Progressed after anthracycline-based chemotherapy and rituximab
- •Evaluable lesions by radiologic study or physical examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome)
- •SGOT and SGPT less than 2 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •Cardiac ejection fraction greater than 50%
- •No cardiac hypertrophy
- •No known conduction heart disease
- •No New York Heart Association class III or IV heart disease that would make it difficult to assess patient during study participation
- •No significant prior heart disease
- •No significant prior secondary or tertiary heart block
- •No significant prior atrial or ventricular arrhythmia requiring therapeutic intervention or antiarrhythmics for rate control
- •No severe debilitating pulmonary disease that would make it difficult to assess patient during study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study participation
- •Potassium ≥ 4.0 mmol/L (supplementation allowed)
- •Magnesium ≥ 2.0 mg/dL (supplementation allowed)
- •No other concurrent active malignancy except basal cell skin cancer
- •No other concurrent significant co-morbidity that would make it difficult to assess patient during study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 2 weeks since prior epoetin alfa or filgrastim (G-CSF)
- •At least 4 weeks since prior cytokines
- •No concurrent immunotherapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior systemic chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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