Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma
Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00028795
Collaborator
National Cancer Institute (NCI) (NIH)
170
230
1
111
0.7
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated with adjuvant temozolomide administered concurrently with postoperative radiotherapy and then alone as maintenance therapy vs historical control cohorts treated in prior Pediatric Oncology Group and Children's Cancer Group studies.
-
Determine the toxicity of this regimen in these patients.
-
Determine the efficacy of this regimen in patients with DIPG.
-
Determine the toxicity of this regimen in patients with DIPG.
OUTLINE: This is a multicenter study.
-
Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or diagnosis*, patients without gross residual disease undergo cranial irradiation 5 days a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross residual disease undergo radiotherapy as above followed by boost radiotherapy for 1 week. All patients receive oral temozolomide once daily beginning within 5 days after initiation of radiotherapy and continuing for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
-
Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *For patients with diffuse intrinsic pontine glioma only
Patients are followed every 3-6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.
Study Design
Study Type:
Interventional
Actual Enrollment
:
170 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
Study Start Date
:
Dec 1, 2002
Actual Primary Completion Date
:
Sep 1, 2007
Actual Study Completion Date
:
Mar 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chemoradiotherapy
|
Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy
|
Outcome Measures
Primary Outcome Measures
- Improved outcome []
- Toxicity as assessed by NCI CTCAE v. 2.0 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | University of South Alabama Cancer Research Institute | Mobile | Alabama | United States | 36604 |
| 3 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 4 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 5 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 6 | Southern California Permanente Medical Group | Downey | California | United States | 90242 |
| 7 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
| 8 | Rebecca and John Moores UCSD Cancer Center | La Jolla | California | United States | 92093-0658 |
| 9 | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 10 | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California | United States | 90801-1428 |
| 11 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027-0700 |
| 12 | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 13 | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | United States | 90095-1781 |
| 14 | Children's Hospital Central California | Madera | California | United States | 93638-8762 |
| 15 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609-1809 |
| 16 | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | United States | 92868 |
| 17 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 18 | Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California | United States | 94304 |
| 19 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 20 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 21 | Kaiser Permanente Medical Center - Sacramento | Sacramento | California | United States | 95825 |
| 22 | Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego | California | United States | 92120 |
| 23 | Children's Hospital and Health Center - San Diego | San Diego | California | United States | 92123-4282 |
| 24 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94143 |
| 25 | Santa Barbara Cottage Hospital | Santa Barbara | California | United States | 93102 |
| 26 | Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara | California | United States | 95051-5386 |
| 27 | General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 28 | Children's Hospital Cancer Center | Denver | Colorado | United States | 80218 |
| 29 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 30 | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut | United States | 06360-7106 |
| 31 | Yale Comprehensive Cancer Center | New Haven | Connecticut | United States | 06520-8064 |
| 32 | Alfred I. duPont Hospital for Children | Wilmington | Delaware | United States | 19899 |
| 33 | Lombardi Cancer Center at Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 34 | Children's National Medical Center | Washington | District of Columbia | United States | 20010-2970 |
| 35 | Broward General Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 36 | Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 37 | University of Florida Shands Cancer Center | Gainesville | Florida | United States | 32610-0296 |
| 38 | Joe DiMaggio Children's Hospital at Memorial | Hollywood | Florida | United States | 33021 |
| 39 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
| 40 | Jackson Memorial Hospital | Miami | Florida | United States | 33136 |
| 41 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
| 42 | Baptist-South Miami Regional Cancer Program | Miami | Florida | United States | 33176-2197 |
| 43 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
| 44 | Nemours Children's Clinic-Orlando | Orlando | Florida | United States | 32806 |
| 45 | Sacred Heart Children's Hospital | Pensacola | Florida | United States | 32504 |
| 46 | All Children's Hospital | St. Petersburg | Florida | United States | 33701 |
| 47 | St. Joseph's Children's Hospital of Tampa | Tampa | Florida | United States | 33677-4227 |
| 48 | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | United States | 33407 |
| 49 | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta | Georgia | United States | 30342 |
| 50 | MBCCOP-Medical College of Georgia Cancer Center | Augusta | Georgia | United States | 30912-4000 |
| 51 | Medical Center of Central Georgia | Macon | Georgia | United States | 31201 |
| 52 | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | United States | 31405 |
| 53 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 54 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859-5000 |
| 55 | St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | United States | 83712 |
| 56 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60601 |
| 57 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 58 | University of Illinois Medical Center | Chicago | Illinois | United States | 60612 |
| 59 | Children's Memorial Hospital - Chicago | Chicago | Illinois | United States | 60614 |
| 60 | Advocate Hope Children's Hospital | Oak Lawn | Illinois | United States | 60453 |
| 61 | Lutheran General Cancer Care Center | Park Ridge | Illinois | United States | 60068-1174 |
| 62 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 63 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62794-9658 |
| 64 | Riley Children Cancer Center at Riley Hospital for Children | Indianapolis | Indiana | United States | 46202-5225 |
| 65 | St. Vincent Hospitals and Health Care Centers | Indianapolis | Indiana | United States | 46260 |
| 66 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 67 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1009 |
| 68 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 69 | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536-0284 |
| 70 | Kosair Children's Hospital | Louisville | Kentucky | United States | 40202-3830 |
| 71 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 72 | Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana | United States | 70112 |
| 73 | Children's Hospital of New Orleans | New Orleans | Louisiana | United States | 70118 |
| 74 | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 75 | Pediatric Specialty Clinic at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 76 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074-9308 |
| 77 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201-1595 |
| 78 | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | United States | 21215 |
| 79 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-7223 |
| 80 | Walter Reed Army Medical Center | Silver Spring | Maryland | United States | 20910 |
| 81 | Floating Hospital for Children | Boston | Massachusetts | United States | 02111 |
| 82 | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 83 | Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield | Massachusetts | United States | 01107 |
| 84 | UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 85 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0914 |
| 86 | Children's Hospital of Michigan | Detroit | Michigan | United States | 48201 |
| 87 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
| 88 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 89 | DeVos Children's Hospital | Grand Rapids | Michigan | United States | 49503 |
| 90 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007-5364 |
| 91 | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | United States | 48910 |
| 92 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073-6769 |
| 93 | St. Mary's - Duluth Clinic Cancer Center | Duluth | Minnesota | United States | 55805 |
| 94 | Children's Hospitals and Clinics - Minneapolis/St. Paul | Minneapolis | Minnesota | United States | 55404 |
| 95 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 96 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 97 | University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 98 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 99 | Cardinal Glennon Children's Hospital | Saint Louis | Missouri | United States | 63104 |
| 100 | St. Louis Children's Hospital | Saint Louis | Missouri | United States | 63110 |
| 101 | Children's Hospital of Omaha | Omaha | Nebraska | United States | 68114 |
| 102 | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-2168 |
| 103 | Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89109 |
| 104 | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 105 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 106 | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08903 |
| 107 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112-2094 |
| 108 | St. Joseph's Hospital and Medical Center | Paterson | New Jersey | United States | 07503 |
| 109 | Valerie Fund Children's Center at Atlantic Health | Summit | New Jersey | United States | 07901 |
| 110 | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | United States | 87131 |
| 111 | Children's Hospital at Albany Medical Center | Albany | New York | United States | 12208 |
| 112 | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York | United States | 10461 |
| 113 | Brooklyn Hospital Center | Brooklyn | New York | United States | 11201-5493 |
| 114 | SUNY Downstate Medical Center | Brooklyn | New York | United States | 11203 |
| 115 | Brookdale University Hospital and Medical Center | Brooklyn | New York | United States | 11212 |
| 116 | Comprehensive Cancer Center at Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
| 117 | Schneider Children's Hospital | New Hyde Park | New York | United States | 11040 |
| 118 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
| 119 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
| 120 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 121 | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | United States | 10032 |
| 122 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 123 | Long Island Cancer Center at Stony Brook University Hospital | Stony Brook | New York | United States | 11794-8174 |
| 124 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 125 | New York Medical College | Valhalla | New York | United States | 10595 |
| 126 | Mission Hospitals - Memorial Campus | Asheville | North Carolina | United States | 28801 |
| 127 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 128 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 129 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233 |
| 130 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 131 | Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville | North Carolina | United States | 27858-4354 |
| 132 | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | United States | 27157-1081 |
| 133 | Dakota Cancer Institute at Innovis Health - Dakota Clinic | Fargo | North Dakota | United States | 58103-4940 |
| 134 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308-1062 |
| 135 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
| 136 | Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland | Ohio | United States | 44106-5065 |
| 137 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 138 | Columbus Children's Hospital | Columbus | Ohio | United States | 43205-2696 |
| 139 | Children's Medical Center - Dayton | Dayton | Ohio | United States | 45404 |
| 140 | Toledo Children's Hospital | Toledo | Ohio | United States | 43601 |
| 141 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
| 142 | Tod Children's Hospital - Forum Health | Youngstown | Ohio | United States | 44501 |
| 143 | Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma | United States | 73104 |
| 144 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
| 145 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
| 146 | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon | United States | 97227 |
| 147 | Doernbecher Children's Hospital at Oregon Health & Science University | Portland | Oregon | United States | 97239-3098 |
| 148 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-1320 |
| 149 | Penn State Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
| 150 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 151 | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134-1095 |
| 152 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 153 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 154 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
| 155 | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina | United States | 29203 |
| 156 | Children's Hospital of Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 157 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105-1080 |
| 158 | Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
| 159 | East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City | Tennessee | United States | 37614-0622 |
| 160 | East Tennessee Children's Hospital | Knoxville | Tennessee | United States | 37901 |
| 161 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 162 | Vanderbilt Children's Hospital | Nashville | Tennessee | United States | 37232-6310 |
| 163 | Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas | United States | 79106 |
| 164 | Children's Hospital of Austin | Austin | Texas | United States | 78701 |
| 165 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 166 | Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75390-9063 |
| 167 | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | United States | 76104 |
| 168 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0209 |
| 169 | M.D. Anderson Cancer Center at University of Texas | Houston | Texas | United States | 77030-4009 |
| 170 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 171 | San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas | United States | 78236 |
| 172 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 173 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78207 |
| 174 | MBCCOP - South Texas Pediatrics | San Antonio | Texas | United States | 78229-3900 |
| 175 | Methodist Cancer Center at Methodist Specialty and Transplant Hospital | San Antonio | Texas | United States | 78229-3902 |
| 176 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 177 | Center for Cancer Prevention and Care at Scott and White Clinic | Temple | Texas | United States | 76508 |
| 178 | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | United States | 84112 |
| 179 | Vermont Cancer Center at University of Vermont | Burlington | Vermont | United States | 05401-3498 |
| 180 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 181 | INOVA Fairfax Hospital | Falls Church | Virginia | United States | 22042-3300 |
| 182 | Children's Hospital of the King's Daughters | Norfolk | Virginia | United States | 23507 |
| 183 | Naval Medical Center - Portsmouth | Portsmouth | Virginia | United States | 23708-5100 |
| 184 | Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | United States | 23298-0121 |
| 185 | Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia | United States | 24029 |
| 186 | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | United States | 98105 |
| 187 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109-1024 |
| 188 | Group Health Central Hospital | Seattle | Washington | United States | 98112 |
| 189 | Deaconess Medical Center | Spokane | Washington | United States | 99210-0248 |
| 190 | Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington | United States | 98415-0299 |
| 191 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-0001 |
| 192 | West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia | United States | 25302 |
| 193 | Cabell Huntington Hospital | Huntington | West Virginia | United States | 25701 |
| 194 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506-9300 |
| 195 | Bellin Memorial Hospital | Green Bay | Wisconsin | United States | 54301 |
| 196 | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 197 | St. Vincent Hospital | Green Bay | Wisconsin | United States | 54307-9070 |
| 198 | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 199 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 200 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | United States | 54449-5772 |
| 201 | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | United States | 54449 |
| 202 | Midwest Children's Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 203 | Sydney Children's Hospital | Randwick | New South Wales | Australia | 2031 |
| 204 | Children's Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 205 | Royal Children's Hospital | Brisbane | Queensland | Australia | 4029 |
| 206 | Women's and Children's Hospital | North Adelaide | South Australia | Australia | 5006 |
| 207 | Royal Children's Hospital | Parkville | Victoria | Australia | 3052 |
| 208 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6001 |
| 209 | Alberta Children's Hospital | Calgary | Alberta | Canada | T2T 5C7 |
| 210 | Cross Cancer Institute at University of Alberta | Edmonton | Alberta | Canada | T6G 1Z2 |
| 211 | British Columbia Children's Hospital | Vancouver | British Columbia | Canada | V6H 3V4 |
| 212 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 213 | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 214 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3J 3G9 |
| 215 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8S 4J9 |
| 216 | Children's Hospital of Western Ontario | London | Ontario | Canada | N6C 2V5 |
| 217 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 218 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 219 | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | Canada | H3G 1A4 |
| 220 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 221 | Centre de Recherche du Centre Hospitalier de l'Universite Laval | Sainte Foy | Quebec | Canada | GIV 4G2 |
| 222 | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | Canada | S4T 7T1 |
| 223 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 224 | University Medical Center Groningen | Groningen | Netherlands | 9700 RB | |
| 225 | Starship Children's Health | Auckland | New Zealand | ||
| 226 | Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus | San Juan | Puerto Rico | 00936-5067 | |
| 227 | San Jorge Children's Hospital | Santurce | Puerto Rico | 00912 | |
| 228 | Swiss Pediatric Oncology Group Bern | Bern | Switzerland | CH 3010 | |
| 229 | Swiss Pediatric Oncology Group Geneva | Geneva | Switzerland | CH 1211 | |
| 230 | Swiss Pediatric Oncology Group Lausanne | Lausanne | Switzerland | CH 1011 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Kenneth J. Cohen, MD, MBA, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00028795
Other Study ID Numbers:
- ACNS0126
- COG-ACNS0126
- CDR0000069135
First Posted:
Jan 27, 2003
Last Update Posted:
Feb 21, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Children's Oncology Group
Additional relevant MeSH terms: