A Phase I/II Open-Label Study Of The Intravenous Administration Of Homoharringtonine (CGX-635) Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events
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 I/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia.
详细描述
OBJECTIVES:
- Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia.
- Determine the antileukemic efficacy of this drug in these patients.
OUTLINE: Patients receive remission induction therapy comprising homoharringtonine (HH) IV continuously on days 1-14. Courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission (CR) is achieved or the patient fails to respond after 3 courses.
Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH IV continuously on days 1-7. Maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction
- •Refractory to tretinoin, anthracyclines, and arsenic-based therapy (including arsenic trioxide) and for which no other alternative therapy of higher priority is appropriate
- •PATIENT CHARACTERISTICS:
- •12 and over
- •Performance status:
- •Zubrod 0-3
- •Life expectancy:
- •More than 4 weeks
- •Hematopoietic:
- •See Disease Characteristics
- •Bilirubin no greater than 2.0 mg/dL
- •ALT no greater than 3 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No active ischemia
- •No other uncontrolled cardiac condition (e.g., angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure)
- •No myocardial infarction within the past 12 weeks
- •No other concurrent illness that would preclude study
- •No other active malignancy
- •No uncontrolled active infection
- •No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia
- •No medical or psychiatric condition that would preclude informed consent or study therapy
- •HIV negative
- •HTLV-I and HTLV-II negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior or concurrent leukapheresis allowed
- •Chemotherapy:
- •See Disease Characteristics
- •At least 15 days since prior systemic chemotherapy unless leukemia progression necessitates early therapy
- •No other concurrent systemic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •Recovered from prior therapy
- •At least 15 days since other prior antileukemic therapy unless leukemia progression necessitates early therapy
- •No other concurrent antileukemic therapy
排除标准
- 未提供
结局指标
主要结局
Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events
Efficacy by response to treatment
次要结局
- Pharmacokinetics
- Duration of treatment response
- Survival
- Induction mortality
- Hospitalizations