Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

capecitabine

This is a dose escalation study. 375, 500, 650, or 850 mg/m2 capecitabine RDT is given orally daily in two divided doses approximately 12 hours apart beginning at the start of radiation therapy and continuing for 9 weeks. After a two week break, patients receive twice daily oral capecitabine, either 900 mg/m2 or 1250 mg/m2, approximately 12 hours apart for 14 days followed by a 7-day rest period for a total of 3 courses.

RADIATION

radiation therapy

Participants receive local radiation once daily, 5 days/week for 9 weeks for a total dose of 5580 cGy.

Trial Locations (12)

15213

Children's Hospital of Pittsburgh, Pittsburgh

27710

Duke Comprehensive Cancer Center, Durham

38105

St. Jude Children's Research Hospital, Memphis

60614

Children's Memorial Hospital - Chicago, Chicago

77030

Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

98105

Children's Hospital and Regional Medical Center - Seattle, Seattle

20010-2970

Children's National Medical Center, Washington D.C.

20892-1182

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda

02115

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston

19104-4318

Children's Hospital of Philadelphia, Philadelphia

77030-2399

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Pediatric Brain Tumor Consortium

NETWORK

NCT00357253 - Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma | Biotech Hunter | Biotech Hunter