新诊断星形细胞瘤、多形性胶质母细胞瘤、胶质肉瘤或弥漫性脑桥脑胶质瘤儿童手术后化疗和放疗
2014年2月19日 更新者：Children's Oncology Group
替莫唑胺治疗儿童高级别胶质瘤的 II 期研究
基本原理：化疗中使用的药物使用不同的方法来阻止肿瘤细胞分裂，从而使它们停止生长或死亡。 放射疗法使用高能 X 射线来破坏肿瘤细胞。 将化疗与放疗一起进行可能会杀死更多的肿瘤细胞。
目的：这项 II 期试验正在研究在新诊断的星形细胞瘤、多形性胶质母细胞瘤、神经胶质肉瘤或弥漫性桥脑神经胶质瘤的儿童中，在手术后单独进行化疗后同时进行化疗和放疗的效果如何。
研究概览
详细说明
目标：
- 比较新诊断的间变性星形细胞瘤、多形性胶质母细胞瘤、胶质肉瘤或弥漫性脑桥脑胶质瘤 (DIPG) 患者的无事件生存期，这些患者接受替莫唑胺辅助治疗，同时接受术后放疗，然后单独作为维持治疗与既往儿科治疗的历史对照队列肿瘤组和儿童癌症组研究。
- 确定该方案对这些患者的毒性。
- 确定该方案对 DIPG 患者的疗效。
- 确定该方案对 DIPG 患者的毒性。
大纲：这是一项多中心研究。
- 辅助放化疗：在手术切除或诊断*后 6 周内开始，无大体残留病灶的患者每周接受 5 天颅内照射，持续 6 周。 从手术切除后 6 周内开始，有大体残留病灶的患者接受上述放疗，然后进行 1 周的加强放疗。 所有患者在放射治疗开始后 5 天内开始每天一次口服替莫唑胺，并在没有疾病进展或不可接受的毒性的情况下持续总共 6 周。
- 辅助维持治疗：辅助放化疗完成后 4 周开始，患者在第 1-5 天接受口服替莫唑胺。 在没有疾病进展或不可接受的毒性的情况下，每 28 天重复治疗一次，总共 10 个疗程。
注意：*仅适用于弥漫性脑桥脑胶质瘤患者
患者每 3-6 个月随访 4 年，之后每年随访一次。
预计应计：本研究将在 12-14 个月内累计招募 50-60 名患者。
研究类型
介入性
注册 (实际的)
170
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Alberta
-
Calgary、Alberta、加拿大、T2T 5C7
- Alberta Children's Hospital
-
Edmonton、Alberta、加拿大、T6G 1Z2
- Cross Cancer Institute at University of Alberta
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V6H 3V4
- British Columbia Children's Hospital
-
-
Manitoba
-
Winnipeg、Manitoba、加拿大、R3E 0V9
- CancerCare Manitoba
-
-
Newfoundland and Labrador
-
St. John's、Newfoundland and Labrador、加拿大、A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
-
-
Nova Scotia
-
Halifax、Nova Scotia、加拿大、B3J 3G9
- IWK Health Centre
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
-
London、Ontario、加拿大、N6C 2V5
- Children's Hospital of Western Ontario
-
Ottawa、Ontario、加拿大、K1H 8L1
- Children's Hospital of Eastern Ontario
-
Toronto、Ontario、加拿大、M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal、Quebec、加拿大、H3T 1C5
- Hôpital Sainte Justine
-
Montreal、Quebec、加拿大、H3G 1A4
- Montreal Children's Hospital at McGill University Health Center
-
Sainte Foy、Quebec、加拿大、GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
-
-
Saskatchewan
-
Regina、Saskatchewan、加拿大、S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
-
Saskatoon、Saskatchewan、加拿大、S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
-
Auckland、新西兰
- Starship Children's Health
-
-
-
-
-
San Juan、波多黎各、00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
-
Santurce、波多黎各、00912
- San Jorge Children's Hospital
-
-
-
-
New South Wales
-
Randwick、New South Wales、澳大利亚、2031
- Sydney Children's Hospital
-
Westmead、New South Wales、澳大利亚、2145
- Children's Hospital at Westmead
-
-
Queensland
-
Brisbane、Queensland、澳大利亚、4029
- Royal Children's Hospital
-
-
South Australia
-
North Adelaide、South Australia、澳大利亚、5006
- Women's and Children's Hospital
-
-
Victoria
-
Parkville、Victoria、澳大利亚、3052
- Royal Children's Hospital
-
-
Western Australia
-
Perth、Western Australia、澳大利亚、6001
- Princess Margaret Hospital for Children
-
-
-
-
-
Bern、瑞士、CH 3010
- Swiss Pediatric Oncology Group Bern
-
Geneva、瑞士、CH 1211
- Swiss Pediatric Oncology Group Geneva
-
Lausanne、瑞士、CH 1011
- Swiss Pediatric Oncology Group Lausanne
-
-
-
-
Alabama
-
Birmingham、Alabama、美国、35233
- Comprehensive Cancer Center at University of Alabama at Birmingham
-
Mobile、Alabama、美国、36604
- University of South Alabama Cancer Research Institute
-
-
Arizona
-
Phoenix、Arizona、美国、85016
- Phoenix Children's Hospital
-
Tucson、Arizona、美国、85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
-
-
Arkansas
-
Little Rock、Arkansas、美国、72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Downey、California、美国、90242
- Southern California Permanente Medical Group
-
Duarte、California、美国、91010-3000
- City of Hope Comprehensive Cancer Center
-
La Jolla、California、美国、92093-0658
- Rebecca and John Moores UCSD Cancer Center
-
Loma Linda、California、美国、92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
-
Long Beach、California、美国、90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
-
Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
Los Angeles、California、美国、90027-0700
- Children's Hospital Los Angeles
-
Los Angeles、California、美国、90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
-
Madera、California、美国、93638-8762
- Children's Hospital Central California
-
Oakland、California、美国、94609-1809
- Children's Hospital and Research Center at Oakland
-
Orange、California、美国、92868
- Children's Hospital of Orange County
-
Orange、California、美国、92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
-
Palo Alto、California、美国、94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
-
Sacramento、California、美国、95816
- Sutter Cancer Center
-
Sacramento、California、美国、95817
- University of California Davis Cancer Center
-
Sacramento、California、美国、95825
- Kaiser Permanente Medical Center - Sacramento
-
San Diego、California、美国、92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
-
San Diego、California、美国、92123-4282
- Children's Hospital and Health Center - San Diego
-
San Francisco、California、美国、94143
- UCSF Comprehensive Cancer Center
-
Santa Barbara、California、美国、93102
- Santa Barbara Cottage Hospital
-
Santa Clara、California、美国、95051-5386
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
-
Travis Air Force Base、California、美国、94535
- General Robert Huyser Cancer Center at David Grant Medical Center
-
-
Colorado
-
Denver、Colorado、美国、80218
- Presbyterian - St. Luke's Medical Center
-
Denver、Colorado、美国、80218
- Children's Hospital Cancer Center
-
-
Connecticut
-
Farmington、Connecticut、美国、06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
-
New Haven、Connecticut、美国、06520-8064
- Yale Comprehensive Cancer Center
-
-
Delaware
-
Wilmington、Delaware、美国、19899
- Alfred I. DuPont Hospital for Children
-
-
District of Columbia
-
Washington、District of Columbia、美国、20007
- Lombardi Cancer Center at Georgetown University Medical Center
-
Washington、District of Columbia、美国、20010-2970
- Children's National Medical Center
-
-
Florida
-
Fort Lauderdale、Florida、美国、33316
- Broward General Medical Center
-
Fort Myers、Florida、美国、33908
- Children's Hospital of Southwest Florida
-
Gainesville、Florida、美国、32610-0296
- University of Florida Shands Cancer Center
-
Hollywood、Florida、美国、33021
- Joe DiMaggio Children's Hospital at Memorial
-
Jacksonville、Florida、美国、32207
- Nemours Children's Clinic
-
Miami、Florida、美国、33155
- Miami Children's Hospital
-
Miami、Florida、美国、33136
- Jackson Memorial Hospital
-
Miami、Florida、美国、33176-2197
- Baptist-South Miami Regional Cancer Program
-
Orlando、Florida、美国、32804
- Florida Hospital Cancer Institute
-
Orlando、Florida、美国、32806
- Nemours Children's Clinic-Orlando
-
Pensacola、Florida、美国、32504
- Sacred Heart Children's Hospital
-
St. Petersburg、Florida、美国、33701
- All Children's Hospital
-
Tampa、Florida、美国、33677-4227
- St. Joseph's Children's Hospital of Tampa
-
West Palm Beach、Florida、美国、33407
- Kaplan Cancer Center at St. Mary's Medical Center
-
-
Georgia
-
Atlanta、Georgia、美国、30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
-
Augusta、Georgia、美国、30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
-
Macon、Georgia、美国、31201
- Medical Center of Central Georgia
-
Savannah、Georgia、美国、31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
-
Hawaii
-
Honolulu、Hawaii、美国、96859-5000
- Tripler Army Medical Center
-
Honolulu、Hawaii、美国、96813
- Cancer Research Center of Hawaii
-
-
Idaho
-
Boise、Idaho、美国、83712
- St. Luke's Mountain States Tumor Institute - Boise
-
-
Illinois
-
Chicago、Illinois、美国、60612
- Rush University Medical Center
-
Chicago、Illinois、美国、60614
- Children's Memorial Hospital - Chicago
-
Chicago、Illinois、美国、60601
- University of Chicago Cancer Research Center
-
Chicago、Illinois、美国、60612
- University of Illinois Medical Center
-
Oak Lawn、Illinois、美国、60453
- Advocate Hope Children's Hospital
-
Park Ridge、Illinois、美国、60068-1174
- Lutheran General Cancer Care Center
-
Peoria、Illinois、美国、61637
- Saint Jude Midwest Affiliate
-
Springfield、Illinois、美国、62794-9658
- Southern Illinois University School of Medicine
-
-
Indiana
-
Indianapolis、Indiana、美国、46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
-
Indianapolis、Indiana、美国、46260
- St. Vincent Hospitals and Health Care Centers
-
-
Iowa
-
Des Moines、Iowa、美国、50309
- Blank Children's Hospital
-
Iowa City、Iowa、美国、52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kansas
-
Wichita、Kansas、美国、67214
- Wesley Medical Center
-
-
Kentucky
-
Lexington、Kentucky、美国、40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
-
Louisville、Kentucky、美国、40202-3830
- Kosair Children's Hospital
-
-
Louisiana
-
New Orleans、Louisiana、美国、70118
- Children's Hospital of New Orleans
-
New Orleans、Louisiana、美国、70112
- MBCCOP - LSU Health Sciences Center
-
New Orleans、Louisiana、美国、70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
-
New Orleans、Louisiana、美国、70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
-
-
Maine
-
Bangor、Maine、美国、04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
-
Scarborough、Maine、美国、04074-9308
- Maine Children's Cancer Program
-
-
Maryland
-
Baltimore、Maryland、美国、21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
-
Baltimore、Maryland、美国、21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
-
Baltimore、Maryland、美国、21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Silver Spring、Maryland、美国、20910
- Walter Reed Army Medical Center
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
Boston、Massachusetts、美国、02111
- Floating Hospital for Children
-
Springfield、Massachusetts、美国、01107
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
-
Worcester、Massachusetts、美国、01655
- UMASS Memorial Cancer Center - University Campus
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109-0914
- University Of Michigan Comprehensive Cancer Center
-
Detroit、Michigan、美国、48201
- Children's Hospital of Michigan
-
Detroit、Michigan、美国、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Flint、Michigan、美国、48503
- Hurley Medical Center
-
Grand Rapids、Michigan、美国、49503
- DeVos Children's Hospital
-
Kalamazoo、Michigan、美国、49007-5364
- Bronson Methodist Hospital
-
Lansing、Michigan、美国、48910
- Breslin Cancer Center at Ingham Regional Medical Center
-
Royal Oak、Michigan、美国、48073-6769
- William Beaumont Hospital - Royal Oak Campus
-
-
Minnesota
-
Duluth、Minnesota、美国、55805
- St. Mary's - Duluth Clinic Cancer Center
-
Minneapolis、Minnesota、美国、55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
-
Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
-
-
Mississippi
-
Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
-
-
Missouri
-
Columbia、Missouri、美国、65203
- University of Missouri - Columbia
-
Kansas City、Missouri、美国、64108
- Children's Mercy Hospital
-
Saint Louis、Missouri、美国、63110
- St. Louis Children's Hospital
-
Saint Louis、Missouri、美国、63104
- Cardinal Glennon Children's Hospital
-
-
Nebraska
-
Omaha、Nebraska、美国、68114
- Children's Hospital of Omaha
-
Omaha、Nebraska、美国、68198-2168
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas、Nevada、美国、89109
- Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
-
New Brunswick、New Jersey、美国、08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
Newark、New Jersey、美国、07112-2094
- Newark Beth Israel Medical Center
-
Paterson、New Jersey、美国、07503
- St. Joseph's Hospital and Medical Center
-
Summit、New Jersey、美国、07901
- Valerie Fund Children's Center at Atlantic Health
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87131
- University of New Mexico Cancer Research and Treatment Center
-
-
New York
-
Albany、New York、美国、12208
- Children's Hospital at Albany Medical Center
-
Bronx、New York、美国、10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Brooklyn、New York、美国、11203
- SUNY Downstate Medical Center
-
Brooklyn、New York、美国、11212
- Brookdale University Hospital and Medical Center
-
Brooklyn、New York、美国、11201-5493
- Brooklyn Hospital Center
-
Brooklyn、New York、美国、11219
- Comprehensive Cancer Center at Maimonides Medical Center
-
New Hyde Park、New York、美国、11040
- Schneider Children's Hospital
-
New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
-
New York、New York、美国、10021
- New York Weill Cornell Cancer Center at Cornell University
-
New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
New York、New York、美国、10029
- Mount Sinai Medical Center
-
Rochester、New York、美国、14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Stony Brook、New York、美国、11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
-
Syracuse、New York、美国、13210
- SUNY Upstate Medical University Hospital
-
Valhalla、New York、美国、10595
- New York Medical College
-
-
North Carolina
-
Asheville、North Carolina、美国、28801
- Mission Hospitals - Memorial Campus
-
Chapel Hill、North Carolina、美国、27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Charlotte、North Carolina、美国、28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte、North Carolina、美国、28233
- Presbyterian Cancer Center at Presbyterian Hospital
-
Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
-
Greenville、North Carolina、美国、27858-4354
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
-
Winston-Salem、North Carolina、美国、27157-1081
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Fargo、North Dakota、美国、58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
-
-
Ohio
-
Akron、Ohio、美国、44308-1062
- Children's Hospital Medical Center of Akron
-
Cincinnati、Ohio、美国、45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland、Ohio、美国、44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
-
Columbus、Ohio、美国、43205-2696
- Columbus Children's Hospital
-
Dayton、Ohio、美国、45404
- Children's Medical Center - Dayton
-
Toledo、Ohio、美国、43601
- Toledo Children's Hospital
-
Toledo、Ohio、美国、43608
- St. Vincent Mercy Medical Center
-
Youngstown、Ohio、美国、44501
- Tod Children's Hospital - Forum Health
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73104
- Children's Hospital at Oklahoma University Medical Center
-
Tulsa、Oklahoma、美国、74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Portland、Oregon、美国、97225
- CCOP - Columbia River Oncology Program
-
Portland、Oregon、美国、97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
-
Portland、Oregon、美国、97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822-1320
- Geisinger Medical Center
-
Hershey、Pennsylvania、美国、17033
- Penn State Children's Hospital
-
Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
-
Philadelphia、Pennsylvania、美国、19134-1095
- St. Christopher's Hospital for Children
-
Pittsburgh、Pennsylvania、美国、15213
- Children's Hospital of Pittsburgh
-
-
Rhode Island
-
Providence、Rhode Island、美国、02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston、South Carolina、美国、29425-0721
- Hollings Cancer Center at Medical University of South Carolina
-
Columbia、South Carolina、美国、29203
- Palmetto Health South Carolina Cancer Center
-
Greenville、South Carolina、美国、29605
- Children's Hospital of Greenville Hospital System
-
-
South Dakota
-
Sioux Falls、South Dakota、美国、57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls、South Dakota、美国、57105-1080
- Avera Cancer Institute
-
-
Tennessee
-
Johnson City、Tennessee、美国、37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
-
Knoxville、Tennessee、美国、37901
- East Tennessee Children's Hospital
-
Memphis、Tennessee、美国、38105
- St. Jude Children's Research Hospital
-
Nashville、Tennessee、美国、37232-6310
- Vanderbilt Children's Hospital
-
-
Texas
-
Amarillo、Texas、美国、79106
- Texas Tech University Health Sciences Center School of Medicine
-
Austin、Texas、美国、78701
- Children's Hospital of Austin
-
Dallas、Texas、美国、75230
- Medical City Dallas Hospital
-
Dallas、Texas、美国、75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
-
Fort Worth、Texas、美国、76104
- Cook Children's Medical Center - Fort Worth
-
Galveston、Texas、美国、77555-0209
- University of Texas Medical Branch
-
Houston、Texas、美国、77030
- Baylor College of Medicine
-
Houston、Texas、美国、77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
Lackland Air Force Base、Texas、美国、78236
- San Antonio Military Pediatric Cancer and Blood Disorders Center
-
Lubbock、Texas、美国、79410
- Covenant Children's Hospital
-
San Antonio、Texas、美国、78207
- University of Texas Health Science Center at San Antonio
-
San Antonio、Texas、美国、78229-3900
- MBCCOP - South Texas Pediatrics
-
San Antonio、Texas、美国、78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
-
Temple、Texas、美国、76508
- CCOP - Scott and White Hospital
-
Temple、Texas、美国、76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
-
Utah
-
Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute at University of Utah
-
-
Vermont
-
Burlington、Vermont、美国、05401-3498
- Vermont Cancer Center at University of Vermont
-
-
Virginia
-
Charlottesville、Virginia、美国、22908
- University of Virginia Cancer Center
-
Falls Church、Virginia、美国、22042-3300
- INOVA Fairfax Hospital
-
Norfolk、Virginia、美国、23507
- Children's Hospital of The King's Daughters
-
Portsmouth、Virginia、美国、23708-5100
- Naval Medical Center - Portsmouth
-
Richmond、Virginia、美国、23298-0121
- Massey Cancer Center at Virginia Commonwealth University
-
Roanoke、Virginia、美国、24029
- Carilion Medical Center for Children at Roanoke Community Hospital
-
-
Washington
-
Seattle、Washington、美国、98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle、Washington、美国、98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle、Washington、美国、98112
- Group Health Central Hospital
-
Spokane、Washington、美国、99210-0248
- Deaconess Medical Center
-
Tacoma、Washington、美国、98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
Tacoma、Washington、美国、98431-0001
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston、West Virginia、美国、25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington、West Virginia、美国、25701
- Cabell Huntington Hospital
-
Morgantown、West Virginia、美国、26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
-
Wisconsin
-
Green Bay、Wisconsin、美国、54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay、Wisconsin、美国、54301
- Bellin Memorial Hospital
-
Green Bay、Wisconsin、美国、54307-9070
- St. Vincent Hospital
-
La Crosse、Wisconsin、美国、54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison、Wisconsin、美国、53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Marshfield、Wisconsin、美国、54449
- CCOP - Marshfield Clinic Research Foundation
-
Marshfield、Wisconsin、美国、54449-5772
- Marshfield Clinic - Marshfield Center
-
Milwaukee、Wisconsin、美国、53226
- Midwest Children's Cancer Center
-
-
-
-
-
Groningen、荷兰、9700 RB
- University Medical Center Groningen
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 21年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
疾病特征：
经组织学证实的新诊断的以下类型的 CNS 肿瘤：
以下组织学之一的高级别神经胶质瘤 (HGG)：
- 间变性星形细胞瘤（III 级）
- 多形性胶质母细胞瘤（IV 级）
- 胶质肉瘤
- 原发性脊髓恶性胶质瘤
弥漫性脑桥脑胶质瘤 (DIPG)
- 通过钆增强 MRI 诊断
- 至少 2/3 的肿瘤位于脑桥并且肿瘤明显起源于脑桥
- 无弥漫性软脑膜病
没有具有弥漫性脑干胶质瘤典型特征的肿瘤，包括以下任何一项：
- 背侧外生性脑干胶质瘤
- 颈髓结合部肿瘤
- 中脑或脑干的局灶性低级别胶质瘤
- 无神经纤维瘤病引起的弥漫性脑干肿大
- 无原发性脑干恶性胶质瘤
- 无 M+ 疾病（CSF 肿瘤或转移性疾病阳性）
- 必须在手术切除（对于 HGG 患者）或诊断（对于 DIPG 患者）后 6 周内开始研究放疗
患者特征：
年龄：
- 3 至 21
性能状态：
- 卡诺夫斯基 50-100% 或
- 兰斯基 50-100%
预期寿命：
- 至少2个月
造血：
- 中性粒细胞绝对计数至少 1,000/mm^3
- 血小板计数至少 100,000/mm^3*
- 血红蛋白至少 10.0 g/dL* 注：*输血独立
肝脏：
- 胆红素不超过正常上限 (ULN) 的 1.5 倍
- SGOT 或 SGPT 低于 ULN 的 2.5 倍
肾脏：
- 肌酐不大于 ULN 的 1.5 倍
其他：
- 无其他并发恶性肿瘤
- 如果抗惊厥药控制良好，则允许并发癫痫发作
- 未怀孕或哺乳
- 妊娠试验阴性
- 生育患者必须在研究治疗期间和完成研究治疗后的 2 个月内使用有效的避孕措施
先前的同步治疗：
生物的：
- 没有同时进行的常规细胞因子支持
化疗：
- 未指定
内分泌治疗：
- 除了中枢神经系统肿瘤患者的颅内压升高外，没有同时使用皮质类固醇
放疗：
- 见疾病特征
外科手术：
- 见疾病特征
其他：
- HGG 或 DIPG 之前没有治疗
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Kenneth J. Cohen, MD, MBA、Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pollack IF, Hamilton RL, Burger PC, Brat DJ, Rosenblum MK, Murdoch GH, Nikiforova MN, Holmes EJ, Zhou T, Cohen KJ, Jakacki RI; Children's Oncology Group. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the Children's Oncology Group. J Neurooncol. 2010 Sep;99(2):155-63. doi: 10.1007/s11060-010-0297-3. Epub 2010 Jul 4.
- Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Nikiforov YE, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Gilles FH, Yates AJ, Zhou T, Cohen KJ, Finlay JL, Jakacki RI; Children's Oncology Group. Mismatch repair deficiency is an uncommon mechanism of alkylator resistance in pediatric malignant gliomas: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Dec 1;55(6):1066-71. doi: 10.1002/pbc.22634.
- Cohen KJ, Heideman RL, Zhou T, Holmes EJ, Lavey RS, Bouffet E, Pollack IF. Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group. Neuro Oncol. 2011 Apr;13(4):410-6. doi: 10.1093/neuonc/noq205. Epub 2011 Feb 22.
- Cohen KJ, Pollack IF, Zhou T, Buxton A, Holmes EJ, Burger PC, Brat DJ, Rosenblum MK, Hamilton RL, Lavey RS, Heideman RL. Temozolomide in the treatment of high-grade gliomas in children: a report from the Children's Oncology Group. Neuro Oncol. 2011 Mar;13(3):317-23. doi: 10.1093/neuonc/noq191.
- Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. doi: 10.1002/cncr.22961.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年12月1日
初级完成 (实际的)
2007年9月1日
研究完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2002年1月4日
首先提交符合 QC 标准的
2003年1月26日
首次发布 (估计)
2003年1月27日
研究记录更新
最后更新发布 (估计)
2014年2月21日
上次提交的符合 QC 标准的更新
2014年2月19日
最后验证
2014年2月1日
更多信息
与本研究相关的术语
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.