NCT00852709终止1 期
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins14 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 14
- 主要终点
- To determine the feasibility, tolerability, toxicities, and MTD of clofarabine followed by fractionated cyclophosphamide in pediatric patients with relapsed or refractory acute leukemias.
研究概览
简要总结
This is a Phase I study designed to determine the MTD and assess the toxicity associated with clofarabine followed by fractionated cyclophosphamide in patients > 1 year of age or < 21 years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients enrolled. Cohorts of 3 to 6 patients each will receive escalated doses of clofarabine followed by fractionated cyclophosphamide until the MTD is reached. There will be no intra-patient dose escalation. Single-agent cyclophosphamide will be administered by 2-hour IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide (see the treatment schema below). A cycle is defined as 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for adolescent/young adult patients.
- •Lansky Performance Index > 50 for pediatric patients less than age 10 years.
- •Laboratory values obtained < 7 days prior to receiving study treatment:
- •Total bilirubin < 1.5 mg/dL unless elevated due to hemolysis. The conjugated serum bilirubin prior to study entry must be within the normal range.
- •Aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 × upper limit of normal (ULN)
- •Serum creatinine < 1.0 mg/dL in adolescent/young adults (patients 12 to 17 years of age). For pediatric patients with serum creatinine above the ULN, creatinine clearance > 90 ml/min/1.73m2 calculated using the Schwartz formula may be enrolled. Collected creatinine clearance may be substituted.
- •Patients 18 years and older (Adult population): Serum creatinine <1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2
- •Cardiac function must be normal per the institution normal as measured by echocardiogram (ECHO) within 7 days.
- •Patients should have no evidence of myositis as detected by abnormal serum creatine kinase and/or myoglobin.
排除标准
- •No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug except for 5-azacytidine, thalidomide, hydroxyurea, imatinib (Gleevec), and interferon which must be discontinued at least 3 days before study entry and the patient should have recovered from the toxic side effects of such therapy. In the instance of progressive disease, anti-leukemia therapy may have been administered within the 2-week period as long but the subject should have recovered from the toxic effects of that therapy. Also, intrathecal therapy may be administered within the 2-week period for subjects with CNS disease.
- •Patients who have had an allogeneic or autologous hematopoietic stem cell transplant.
- •Patients must have discontinued all growth factors, except Procrit (epoetin), at least 1 week before study.
- •Patients with known HIV positive status or AIDS.
- •Patients with known active Hepatitis B, Hepatitis C or cirrhosis.
- •History of severe coronary artery disease, including myocardial infarction within the previous 3 months, arrhythmias other than atrial flutter or fibrillation requiring medication, or uncontrolled congestive heart failure.
- •Patients with active uncontrolled infection, fever of infection, or evidence for progressive disease by CT scans of the lungs, sinuses, or abdomen. Patients who are on antimicrobial therapy and stable, CT scans must have been stable for 4 weeks, may be enrolled but there must be no evidence of an active infection. Patients with fever due to leukemia may be enrolled.
- •Pregnant or lactating patients. Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before study entry.
结局指标
主要结局
To determine the feasibility, tolerability, toxicities, and MTD of clofarabine followed by fractionated cyclophosphamide in pediatric patients with relapsed or refractory acute leukemias.
时间窗: 1 cycle
次要结局
- To obtain preliminary descriptive data of the biologic and pharmacodynamic effects of clofarabine followed by fractionated cyclophosphamide on marrow and circulating leukemic blasts in pediatric patients with relapsed or refractory acute leukemias.(1 cycle)
研究者
研究点 (14)
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