A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
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.
Interventional
Primary Purpose: Treatment
Improved outcome
No
Kenneth J. Cohen, MD, MBA
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000069135
NCT00028795
December 2002
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
New York Medical College | Valhalla, New York 10595 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Deaconess Medical Center | Spokane, Washington 99210-0248 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Sutter Cancer Center | Sacramento, California 95816 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
Joe DiMaggio Children's Hospital at Memorial | Hollywood, Florida 33021 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Nemours Children's Clinic-Orlando | Orlando, Florida 32806 |
Sacred Heart Children's Hospital | Pensacola, Florida 32504 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Wesley Medical Center | Wichita, Kansas 67214 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Floating Hospital for Children | Boston, Massachusetts 02111 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Santa Barbara Cottage Hospital | Santa Barbara, California 93102 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
Children's Hospital of Omaha | Omaha, Nebraska 68114 |
Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
Brooklyn Hospital Center | Brooklyn, New York 11201 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Children's Medical Center - Dayton | Dayton, Ohio 45404 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Toledo Children's Hospital | Toledo, Ohio 43601 |
Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Texas Tech University Health Sciences Center School of Medicine | Amarillo, Texas 79106 |
Children's Hospital of Austin | Austin, Texas 78701 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
St. Vincent Hospitals and Health Care Centers | Indianapolis, Indiana 46260 |
Nevada Cancer Research Foundation | Las Vegas, Nevada 89109 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75390 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
Children's Hospital and Health Center - San Diego | San Diego, California 92123-4282 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
Blank Children's Hospital | Des Moines, Iowa 50309 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Group Health Central Hospital | Seattle, Washington 98104 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta, Georgia 30342 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Penn State Children's Hospital | Hershey, Pennsylvania 17033-0850 |
Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke, Virginia 24014 |
Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma, Washington 98405 |
University of South Alabama Cancer Research Institute | Mobile, Alabama 36604 |
Children's Hospital and Research Center at Oakland | Oakland, California 94609-1809 |
Kaiser Permanente Medical Center - Sacramento | Sacramento, California 95825 |
Jackson Memorial Hospital | Miami, Florida 33136 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
University of Illinois Medical Center | Chicago, Illinois 60612 |
Riley Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
Valerie Fund Children's Center at Atlantic Health | Summit, New Jersey 07901 |
Comprehensive Cancer Center at Maimonides Medical Center | Brooklyn, New York 11219 |
Dakota Cancer Institute at Innovis Health - Dakota Clinic | Fargo, North Dakota 58103-4940 |
Children's Hospital at Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Doernbecher Children's Hospital at Oregon Health & Science University | Portland, Oregon 97239-3098 |
East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City, Tennessee 37604 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
Methodist Cancer Center at Methodist Specialty and Transplant Hospital | San Antonio, Texas 78229-3902 |
MBCCOP - South Texas Pediatrics | San Antonio, Texas 78229-3900 |
Center for Cancer Prevention and Care at Scott and White Clinic | Temple, Texas 76508 |
Cabell Huntington Hospital | Huntington, West Virginia 25701 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base, California 94535 |
Children's Hospital Cancer Center | Denver, Colorado 80218 |
St. Joseph's Children's Hospital of Tampa | Tampa, Florida 33677-4227 |
Pediatric Specialty Clinic at Eastern Maine Medical Center | Bangor, Maine 04401 |
Walter Reed Army Medical Center | Silver Spring, Maryland 20910 |
DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
Children's Hospitals and Clinics - Minneapolis/St. Paul | Minneapolis, Minnesota 55404 |
University of Missouri - Columbia | Columbia, Missouri 65203 |
Children's Hospital at Albany Medical Center | Albany, New York 12208 |
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville, North Carolina 27858-4354 |
Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |