Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old
OBJECTIVES:
- Compare the event free survival as a result of treatment with carboplatin and
vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children
with progressive brain tumors.
- Estimate tumor response rates to each regimen of chemotherapy in these patients.
- Determine toxic effects and quality of life of children treated with each regimen of
chemotherapy.
- Investigate biological and clinical factors which may predict tumor response and early
progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative
index by MIB-1 (Ki67)) in these patients.
- Investigate factors contributing to neuropsychological and endocrine status of children
with brain tumors treated without irradiation.
OUTLINE: This is a randomized study. Patients are stratified according to site of disease,
status at entry, and pathology. Patients are randomized to one of two treatment arms.
Patients with neurofibromatosis are nonrandomly assigned to arm II.
- Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks
followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance
beginning on day 84 of induction or upon hematopoietic recovery. Each course consists
of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently
with the first 3 weeks of carboplatin), followed by 2 weeks of rest.
- Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4,
followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a
maximum of 8 courses.
PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Joann Ater, MD
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
CDR0000065394
NCT00002944
April 1997
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
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 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
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 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Sutter Cancer Center | Sacramento, California 95816 |
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 and Regional Medical Center - Seattle | Seattle, Washington 98105 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Wesley Medical Center | Wichita, Kansas 67214 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
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 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
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 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
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 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Santa Barbara Cottage Children's Hospital | Santa Barbara, California 93105 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
Broward General Medical Center Cancer Center | Ft. Lauderdale, Florida 33316 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Blank Children's Hospital | Des Moines, Iowa 50309 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
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 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Group Health Central Hospital | Seattle, Washington 98104 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
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 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Children's Hospital and Research Center Oakland | Oakland, California 94609 |
Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta, Georgia 30322 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta, Georgia 30342 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Simmons Cooper Cancer Institute | Springfield, Illinois 62794-9677 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
CancerCare of Maine at Eastern Maine Medical Center | Bangor, Maine 04401 |
Maine Children's Cancer Program at Barbara Bush Children's Hospital | Scarborough, Maine 04074-9308 |
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
Children's Hospitals and Clinics of Minnesota - St. Paul | St. Paul, Minnesota 55102-2392 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Keesler Air Force Base Medical Center | Keesler AFB, Mississippi 39534-2511 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Children's Hospital | Omaha, Nebraska 68114-4113 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
St. Barnabas Medical Center Cancer Center | Livingston, New Jersey 07039 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Albany Medical Center Hospital | Albany, New York 12208-3419 |
Maimonides Cancer Center at Maimonides Medical Center | Brooklyn, New York 11219 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Beth Israel Medical Center - Petrie Division | New York, New York 10003-3803 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York, New York 10027 |
Dakota Cancer Institute at Dakota Clinic - South University | Fargo, North Dakota 58103-4940 |
Akron Children's Hospital | Akron, Ohio 44308-1062 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Dayton Children's - Dayton | Dayton, Ohio 45404-1815 |
Tod Children's Hospital | Youngstown, Ohio 44501 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Penn State Children's Hospital | Hershey, Pennsylvania 17033-0850 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Dell Children's Medical Center of Central Texas | Austin, Texas 78723 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke, Virginia 24014 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma, Washington 98405 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |