A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

NCT ID: NCT01118377

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2013-04-30

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.

Conditions

Brainstem Glioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine + radiation therapy

Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Capecitabine was supplied as film-coated tablets.

Radiation therapy

Intervention Type: RADIATION

Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.

Interventions

Capecitabine

Capecitabine was supplied as film-coated tablets.

Intervention Type: DRUG

Radiation therapy

Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.

Intervention Type: RADIATION

Other Intervention Names

Xeloda

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Brain Tumor Consortium

NETWORK

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

San Francisco, California, United States

Washington D.C., 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

Countries

United States

Other Identifiers

PBTC-030

Identifier Type: -

Identifier Source: secondary_id

NO21125

Identifier Type: -

Identifier Source: org_study_id