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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 Survival

Percentage 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

Page last updated: August 23, 2015

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