Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma

NCT00028795 | Completed Phase 2 DMC

• 3 other identifiers: ACNS0126COG-ACNS0126CDR0000069135
• Study Type: interventional
• Target: 170
• Locations: 7 countries
• Sites: 230

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood brain stem glioma; childhood high-grade cerebral astrocytoma; childhood spinal cord neoplasm; untreated childhood brain stem glioma

Outcome Measures

Primary Outcomes (2)

• Improved outcome

• Toxicity as assessed by NCI CTCAE v. 2.0

Study Arms (1)

Chemoradiotherapy

EXPERIMENTAL

Drug: temozolomide; Procedure: adjuvant therapy; Radiation: radiation therapy

Interventions

temozolomide DRUG

Chemoradiotherapy

adjuvant therapy PROCEDURE

Chemoradiotherapy

radiation therapy RADIATION

Chemoradiotherapy

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed CNS tumor of the following types: * High grade glioma (HGG) of one of the following histologies: * Anaplastic astrocytoma (grade III) * Glioblastoma multiforme (grade IV) * Gliosarcoma * Primary spinal cord malignant glioma * Diffuse intrinsic pontine glioma (DIPG) * Diagnosed by gadolinium-enhanced MRI * At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons * No diffuse leptomeningeal disease * No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following: * Dorsally exophytic brainstem glioma * Cervico-medullary junction tumor * Focal low-grade glioma of the midbrain or brainstem * No diffuse brainstem enlargement due to neurofibromatosis * No primary brain stem malignant glioma * No M+ disease (CSF positive for tumor or metastatic disease) * Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients) PATIENT CHARACTERISTICS: Age: * 3 to 21 Performance status: * Karnofsky 50-100% OR * Lansky 50-100% Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3\* * Hemoglobin at least 10.0 g/dL\* NOTE: \*Transfusion independent Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT less than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * No other concurrent malignancy * Concurrent seizure disorder allowed if well controlled on anticonvulsants * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after completion of study treatment PRIOR CONCURRENT THERAPY: Biologic: * No concurrent routine cytokine support Chemotherapy: * Not specified Endocrine therapy: * No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics Other: * No prior therapy for HGG or DIPG

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (230)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of South Alabama Cancer Research Institute

Mobile, Alabama, 36604, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801-1428, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Children's Hospital and Health Center - San Diego

San Diego, California, 92123-4282, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051-5386, United States

Location

General Robert Huyser Cancer Center at David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Children's Hospital Cancer Center

Denver, Colorado, 80218, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8064, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0296, United States

Location

Joe DiMaggio Children's Hospital at Memorial

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176-2197, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Nemours Children's Clinic-Orlando

Orlando, Florida, 32806, United States

Location

Sacred Heart Children's Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, 33677-4227, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

Atlanta, Georgia, 30342, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-4000, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31405, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60601, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1174, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9658, United States

Location

Riley Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

Location

St. Vincent Hospitals and Health Care Centers

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0284, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202-3830, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Pediatric Specialty Clinic at Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074-9308, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201-1595, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-7223, United States

Location

Walter Reed Army Medical Center

Silver Spring, Maryland, 20910, United States

Location

Floating Hospital for Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, 01107, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0914, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007-5364, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073-6769, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Children's Hospitals and Clinics - Minneapolis/St. Paul

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Omaha

Omaha, Nebraska, 68114, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-2168, United States

Location

Nevada Cancer Research Foundation

Las Vegas, Nevada, 89109, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112-2094, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Valerie Fund Children's Center at Atlantic Health

Summit, New Jersey, 07901, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Children's Hospital at Albany Medical Center

Albany, New York, 12208, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201-5493, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Comprehensive Cancer Center at Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11040, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794-8174, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1081, United States

Location

Dakota Cancer Institute at Innovis Health - Dakota Clinic

Fargo, North Dakota, 58103-4940, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43601, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-1320, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, 29203, United States

Location

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105-1080, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37614-0622, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37901, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232-6310, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Children's Hospital of Austin

Austin, Texas, 78701, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9063, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

MBCCOP - South Texas Pediatrics

San Antonio, Texas, 78229-3900, United States

Location

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, 78229-3902, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Center for Cancer Prevention and Care at Scott and White Clinic

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-5100, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0121, United States

Location

Carilion Medical Center for Children at Roanoke Community Hospital

Roanoke, Virginia, 24029, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Mary Bridge Children's Hospital and Health Center - Tacoma

Tacoma, Washington, 98415-0299, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-0001, United States

Location

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

Charleston, West Virginia, 25302, United States

Location

Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-9070, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449-5772, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Brisbane, Queensland, 4029, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8S 4J9, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6C 2V5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre de Recherche du Centre Hospitalier de l'Universite Laval

Sainte-Foy, Quebec, GIV 4G2, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Starship Children's Health

Auckland, New Zealand

Location

Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

Swiss Pediatric Oncology Group Bern

Bern, CH 3010, Switzerland

Location

Swiss Pediatric Oncology Group Geneva

Geneva, CH 1211, Switzerland

Location

Swiss Pediatric Oncology Group Lausanne

Lausanne, CH 1011, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 20607350 BACKGROUND

• 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.

  PMID: 20589656 BACKGROUND

• 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.

  PMID: 21345842 RESULT

• 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.

  PMID: 21339192 RESULT

• 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.

  PMID: 17705175 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Spinal Cord Neoplasms

Interventions

Temozolomide; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Spinal Cord Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Kenneth J. Cohen, MD, MBA

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: December 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: March 1, 2012
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

CH (3); US (202); CA (15); NL (1); NZ (1); PR (2); AU (6)