Topotecan in Treating Children With Refractory Leukemia
TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY
研究概览
详细说明
OBJECTIVES:
I. Describe the qualitative and quantitative toxic effects, including acute and chronic dose-limiting toxicity, cumulative toxicity, and time to recovery, in pediatric patients with refractory leukemia who are treated with a 30-minute daily infusion of topotecan (TOPO) for up to 12 consecutive days every 3 weeks.
II. Estimate the maximum tolerated dose of TOPO that results in tolerable, predictable, and reversible toxicity.
III. Determine the precautions and supportive therapy that should be used and the clinical and laboratory studies needed to monitor or alter therapy to prevent unacceptable toxicity in these patients.
IV. Observe any antileukemic effects that may occur during this phase I study in which duration of treatment is increased from 7 to 9 and then 12 days and TOPO doses are escalated.
V. Determine the recommended phase II pediatric dose of TOPO. VI. Characterize the pharmacokinetic parameters of TOPO and evaluate changes in these parameters with the first and last doses to determine whether there is drug accumulation.
VII. Correlate, if possible, these pharmacokinetic parameters with clinical response and toxicity.
OUTLINE:
Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H3H 1P3
- Montreal Children's Hospital
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Montreal、Quebec、加拿大、H3T 1C5
- Hopital Sainte Justine
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San Juan、波多黎各、00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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Geneva、瑞士、1211
- Clinique de Pediatrie
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama Comprehensive Cancer Center
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Arkansas
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Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
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California
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La Jolla、California、美国、92093-0658
- University of California San Diego Cancer Center
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Palo Alto、California、美国、94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Gainesville、Florida、美国、32610-100277
- Shands Hospital and Clinics, University of Florida
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago、Illinois、美国、60614
- Children's Memorial Hospital, Chicago
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Kansas
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Kansas City、Kansas、美国、66160-7357
- University of Kansas Medical Center
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Wichita、Kansas、美国、67214
- Via Christi Regional Medical Center
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Louisiana
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New Orleans、Louisiana、美国、70112
- MBCCOP - LSU Medical Center
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
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Boston、Massachusetts、美国、02111
- Boston Floating Hospital Infants and Children
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Michigan
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Detroit、Michigan、美国、48201
- Children's Hospital of Michigan
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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New York
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Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
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Syracuse、New York、美国、13210
- State University of New York - Upstate Medical University
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North Carolina
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Asheville、North Carolina、美国、28801
- Memorial Mission Hospital
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Tennessee
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Memphis、Tennessee、美国、38105-2794
- Saint Jude Children's Research Hospital
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Texas
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Dallas、Texas、美国、75230
- Medical City Dallas Hospital
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Dallas、Texas、美国、75235-9154
- Simmons Cancer Center - Dallas
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Houston、Texas、美国、77030
- Baylor College of Medicine
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Lackland Air Force Base、Texas、美国、78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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San Antonio、Texas、美国、78284-7811
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Midwest Children's Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
-Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists
PATIENT CHARACTERISTICS:
- Age: Under 21
- Performance status: ECOG 0-2
- Life expectancy: At least 8 weeks
- Adequate platelet count and hemoglobin required (transfusion allowed)
- Bilirubin no greater than 1.5 mg/dL
- AST or ALT no greater than 2 times normal
- Creatinine less than 1.5 mg/dL
- Adequate nutritional status, e.g. higher than third percentile weight for height
- Albumin at least 3 g/dL
- No severe uncontrolled infection
- No pregnant women
- Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas)
- Recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation)
- No concurrent anticancer therapy
- No concurrent treatment studies
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm I
Single-Agent Chemotherapy.
Topotecan, TOPO, NSC-609699.
|
合作者和调查者
调查人员
- 学习椅：Wayne Lee Furman, MD、St. Jude Children's Research Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NCI-2012-01833
- POG-9575
- CDR0000064511 (注册表标识符：PDQ (Physician Data Query))
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
白血病的临床试验
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Shenzhen Second People's Hospital招聘中白血病 | 骨髓的 | 慢性的 | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | 积极的中国
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