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Brief Title: A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
Official Title: A Phase II Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
Study ID: NCT01118377
Brief Summary: This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.
Detailed Description: The open-label phase 2 study NO21125 (NCT01118377) evaluated the progression-free survival, safety, and pharmacokinetics of capecitabine (Xeloda®) rapidly disintegrating tablets and concomitant radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma. There were 2 phases to the study: A 9-week radiation phase, followed by a 2-week rest period, and a 9-week post-radiation phase. In the radiation phase, capecitabine 650 mg/m\^2 was administered orally twice daily for 9 weeks. Concomitantly, patients received radiation therapy (180 cGy fractions) 5 days a week for a total target dose of 56 Gy. During the 9-week post-radiation phase of the study, capecitabine 1250 mg/m\^2 was administered orally twice daily for 14 days followed by a 7-day rest period. This cycle of 14 days treatment followed by 7 days rest was repeated 2 additional times. The dose could be adjusted according to toxicity and body surface area. The single-arm phase 1 study NO18517 (NCT00532948) assessed the maximum tolerated dose and dose-limiting toxicities of capecitabine (Xeloda®) administered concurrently with radiation therapy in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Patients in the phase 1 study NO18517 who were diagnosed with intrinsic brainstem glioma and who were treated at the established maximum tolerated dose of capecitabine 650 mg/m\^2/dose twice a day were included in the analyses of the phase 2 study NO21125. The efficacy and safety results of study NO21125 are reported below.
Minimum Age: 3 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
, San Francisco, California, United States
, Washington, District of Columbia, United States
, Chicago, Illinois, United States
, Durham, North Carolina, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Memphis, Tennessee, United States
, Houston, Texas, United States
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR