Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial
PRIMARY OBJECTIVES:
l. To compare the overall survival (OS) of subjects receiving the combination of
temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan, and
bevacizumab for recurrent medulloblastoma (MB)/PNET of childhood.
SECONDARY OBJECTIVES:
I. To assess the response rate for each treatment arm. II. To determine event-free survival
(EFS) for each patient compared across regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral temozolomide and irinotecan hydrochloride IV over 90 minutes on
days 1-5.
ARM II: Patients receive oral temozolomide and irinotecan hydrochloride IV as in arm I and
bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival for each treatment arm
Up to 5 years
No
Adam Levy
Principal Investigator
Children's Oncology Group
United States: Food and Drug Administration
NCI-2011-02605
NCT01217437
November 2010
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Mayo Clinic | Rochester, Minnesota 55905 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Dell Children's Medical Center of Central Texas | Austin, Texas 78723 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Lee Memorial Health System | Fort Myers, Florida 33902 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Children's Hospital of Alabama | Birmingham, Alabama 35233 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
Wayne State University | Detroit, Michigan 48202 |
Legacy Emanuel Children's Hospital | Portland, Oregon 97227 |
BI-LO Charities Children's Cancer Center | Greenville, South Carolina 29605 |
University Of Vermont | Burlington,, Vermont 05403 |
Albany Medical Center | Albany, New York 12208 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Oregon Health and Science University | Portland, Oregon 97201 |
Virginia Commonwealth University | Richmond, Virginia |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Childrens Memorial Hospital | Chicago, Illinois 60614 |
Kaiser Permanente-Oakland | Oakland, California 94611 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Luke's Mountain States Tumor Institute | Boise, Idaho 83712 |
Michigan State University - Breslin Cancer Center | East Lansing, Michigan 48824-1313 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Saint Barnabas Medical Center | Livingston, New Jersey 07039 |
New York University Langone Medical Center | New York, New York 10016 |
Columbia University Medical Center | New York, New York 10032 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
The Children's Medical Center of Dayton | Dayton, Ohio 45404 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
C S Mott Children's Hospital | Ann Arbor, Michigan 48109 |
Riley Hospital for Children | Indianapolis, Indiana 46202 |
Cardinal Glennon Children's Medical Center | St. Louis, Missouri 63104 |
Miller Children's Hospital | Long Beach, California 90806 |
Childrens Hospital of Orange County | Orange, California 92868-3874 |
Alfred I duPont Hospital for Children | Wilmington, Delaware 19803 |
Nemours Children's Clinic - Jacksonville | Jacksonville, Florida 32207-8426 |
Nemours Childrens Clinic - Orlando | Orlando, Florida 32806 |
Saint Joseph Children's Hospital of Tampa | Tampa, Florida 33607 |
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia 30322 |
The Childrens Mercy Hospital | Kansas City, Missouri 64108 |
Rainbow Babies and Childrens Hospital | Cleveland, Ohio 44106 |
Penn State Hershey Children's Hospital | Hershey, Pennsylvania 17033 |
Palmetto Health Richland | Columbia, South Carolina 29203 |
East Tennessee Childrens Hospital | Knoxville, Tennessee 37916 |
Childrens Hospital-King's Daughters | Norfolk, Virginia 23507 |
Lucile Packard Children's Hospital Stanford University | Palo Alto, California 94304 |
University of California San Francisco Medical Center-Parnassus | San Francisco, California 94143 |
Raymond Blank Children's Hospital | Des Moines, Iowa 50309 |
Greenville Cancer Treatment Center | Greenville, South Carolina 29605 |
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington 99204 |