A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

Roche

Status and phase: Completed; Phase 1

Conditions: Glioma

Treatments: Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532948

NO18517

Details and patient eligibility

About

This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.

Enrollment: 24 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients >=3 and <=21 years of age;
• newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma;
• Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;
• adequate organ function.

Exclusion criteria

• previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
• uncontrolled infection;
• known DPD deficiency.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

1

Experimental group

Treatment:

Drug: capecitabine [Xeloda]