A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brainstem Glioma
Intervention: Capecitabine (Drug); Radiation therapy (Radiation)
Phase: Phase 2
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Summary
This study evaluated the effect of capecitabine and concomitant radiation therapy in
children with newly diagnosed brainstem gliomas.
Clinical Details
Official title: A Phase II Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-free Survival
Secondary outcome: Overall SurvivalPercentage of Participants With a Tumor Response
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.
Eligibility
Minimum age: 3 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pediatric and adolescent patients ≥ 3 to < 18 years of age.
- Patients must have a newly diagnosed non-disseminated intrinsic infiltrating
brainstem glioma.
- Karnofsky Performance Scale (if > 16 years of age) or Lansky Performance Score (if ≤
16 years of age) ≥ 50% assessed within 2 weeks prior to registration to study.
- Patients must not have received any prior chemotherapy or bone marrow transplant for
the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
- Adequate organ function.
Exclusion Criteria:
- Patients receiving any other anticancer or experimental drug therapy.
- Patients with uncontrolled infection.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Locations and Contacts
San Francisco, California 94143-0780, United States
Washington, District of Columbia 20010, United States
Chicago, Illinois 60614, United States
Durham, North Carolina 27710, United States
Philadelphia, Pennsylvania 19104, United States
Pittsburgh, Pennsylvania 15261, United States
Memphis, Tennessee 38015, United States
Houston, Texas 77030, United States
Additional Information
Starting date: May 2007
Last updated: February 4, 2014
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