A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas
OBJECTIVES:
Primary
- Determine the feasibility and toxicity of an induction and maintenance regimen
comprising carboplatin, vincristine, and temozolomide in children with progressive
and/or symptomatic low-grade gliomas.
Secondary
- Determine response rate in patients treated with this regimen.
- Determine 3-year progression-free survival and overall survival of patients treated
with this regimen.
- Correlate response and progression-free survival with the genomic profile of tumors in
patients treated with this regimen.
OUTLINE: This is a pilot study.
- Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and
22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days
43-47. Four weeks after the completion of induction therapy, patients achieving stable
or responding disease proceed to maintenance therapy.
- Maintenance therapy: Patients receive carboplatin and temozolomide as in induction
therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a
total of 6 courses in the absence of disease progression.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of delivering this chemotherapy regimen at 24 weeks
Feasibility defined as the ability to administer induction plus one maintenance cycle
24 weeks
No
Murali M. Chintagumpala, MD
Study Chair
Texas Children's Cancer Center
United States: Federal Government
ACNS0223
NCT00077207
July 2004
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
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 of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
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 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
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 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
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 |
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 |
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 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
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 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Blank Children's Hospital | Des Moines, Iowa 50309 |
CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
Floating Hospital for Children at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
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 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
Children's Hospital | Omaha, Nebraska 68114-4113 |
Albany Medical Center Hospital | Albany, New York 12208-3419 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
T.C. Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
Banner Desert Medical Center | Mesa, Arizona 85202 |
Children's Hospital & Research Center Oakland | Oakland, California 94609 |