Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia
Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.
研究概览
地位
条件
详细说明
OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia. II. Determine the feasibility of delivering 6 courses of this therapy in these patients.
OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually for ten years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2T 5C7
- Alberta Children's Hospital
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Ontario
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Ottawa、Ontario、加拿大、K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal、Quebec、加拿大、H3H 1P3
- Montreal Children's Hospital
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Sainte Foy、Quebec、加拿大、GIV 4G2
- Centre Hospitalier de l'Université Laval
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Santurce、波多黎各、00912
- San Jorge Childrens Hospital
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Geneva、瑞士、1211
- Clinique de Pediatrie
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Arizona
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Tucson、Arizona、美国、85724
- Arizona Cancer Center
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California
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Palo Alto、California、美国、94304
- Lucile Packard Children's Hospital at Stanford
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Sacramento、California、美国、95816
- Sutter Cancer Center
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San Diego、California、美国、92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego、California、美国、92134-3202
- Naval Medical Center - San Diego
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Santa Clara、California、美国、95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Florida
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Jacksonville、Florida、美国、32207
- Nemours Children's Clinic
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Miami、Florida、美国、33136
- Sylvester Cancer Center, University of Miami
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Miami、Florida、美国、33176-2197
- Baptist Hospital of Miami
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Orlando、Florida、美国、32803
- Walt Disney Memorial Cancer Institute
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West Palm Beach、Florida、美国、33407
- St. Mary's Hospital
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu、Hawaii、美国、96859-5000
- Tripler Army Medical Center
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Illinois
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Chicago、Illinois、美国、60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago、Illinois、美国、60614
- Children's Memorial Hospital, Chicago
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Oak Lawn、Illinois、美国、60453
- Christ Hospital
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Peoria、Illinois、美国、61602
- Saint Jude Midwest Affiliate
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Kansas
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Wichita、Kansas、美国、67214
- Via Christi Regional Medical Center-Saint Francis Campus
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Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane University School of Medicine
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Maine
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Bangor、Maine、美国、04401
- Eastern Maine Medical Center
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Portland、Maine、美国、04101
- Maine Children's Cancer Program
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit、Michigan、美国、48236
- St. John's Hospital and Medical Center
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Flint、Michigan、美国、48503
- Hurley Medical Center
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Mississippi
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Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
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Keesler AFB、Mississippi、美国、39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia、Missouri、美国、65212
- University of Missouri-Columbia Hospital and Clinics
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Norris Cotton Cancer Center
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New Mexico
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Albuquerque、New Mexico、美国、87131
- University of New Mexico School of Medicine
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New York
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Stony Brook、New York、美国、11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73126-0307
- Oklahoma Memorial Hospital
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Tulsa、Oklahoma、美国、74136
- Natalie Warren Bryant Cancer Center
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Tennessee
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Johnson City、Tennessee、美国、37614-0622
- James H. Quillen College of Medicine
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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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Fort Worth、Texas、美国、76104
- Cook Children's Medical Center - Fort Worth
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Galveston、Texas、美国、77555-1329
- University of Texas Medical Branch
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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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Temple、Texas、美国、76508
- Scott and White Clinic
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Vermont
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Burlington、Vermont、美国、05401-3498
- Vermont Cancer Center
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Virginia
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Falls Church、Virginia、美国、22046
- INOVA Fairfax Hospital
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Roanoke、Virginia、美国、24029
- Carilion Roanoke Memorial Hospital
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Washington
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Tacoma、Washington、美国、98431-5000
- Madigan Army Medical Center
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West Virginia
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Charleston、West Virginia、美国、25304
- West Virginia University Medical School, Charleston Division
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Morgantown、West Virginia、美国、26506-9162
- West Virginia University Hospitals
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Wisconsin
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Green Bay、Wisconsin、美国、54307-3508
- St. Vincent Hospital
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Milwaukee、Wisconsin、美国、53226
- Midwest Children's Cancer Center
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Groningen、荷兰、9713 EZ
- Academisch Ziekenhuis Groningen
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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 newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor)
PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400
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 |
|---|---|
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实验性的：Chemotherapy Treatment
See detailed description.
|
其他名称：
其他名称：
其他名称：
其他名称：
其他名称：
其他名称：
其他名称：
其他名称：
其他名称：
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Event-free survival
大体时间：7 years
|
7 years
|
合作者和调查者
调查人员
- 学习椅：Naomi J. Winick, MD、Simmons Cancer Center
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
其他相关的 MeSH 术语
- 组织学类型的肿瘤
- 肿瘤
- 白血病
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 自主代理
- 周围神经系统药物
- 抗病毒药物
- 核酸合成抑制剂
- 酶抑制剂
- 抗炎药
- 抗风湿药
- 抗代谢药、抗肿瘤药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 微管蛋白调节剂
- 抗有丝分裂剂
- 有丝分裂调节剂
- 止吐药
- 胃肠道药物
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 抗肿瘤药，激素
- 保护剂
- 抗肿瘤药，烷基化
- 烷化剂
- 清髓性激动剂
- 抗肿瘤药，植物性
- 拓扑异构酶 II 抑制剂
- 拓扑异构酶抑制剂
- 皮肤病药物
- 微量元素
- 抗生素、抗肿瘤药
- 维生素
- 生殖控制剂
- 解毒剂
- 复合维生素B
- 堕胎药，非甾体
- 堕胎剂
- 叶酸拮抗剂
- 地塞米松
- 环磷酰胺
- 亚叶酸
- 左旋叶酸
- 阿糖胞苷
- 甲氨蝶呤
- 长春新碱
- 柔红霉素
- 门冬酰胺酶
- 巯嘌呤
- 硫鸟嘌呤
其他研究编号
- 9705
- POG-9705 (其他标识符：Pediatric Oncology Group)
- CDR0000066768 (其他标识符：Clinical Trials.gov)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.