NCT00514397

Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.

Detailed description

OBJECTIVES: Primary * To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide. * To assess the quality of life of patients with diffuse pontine gliomas during and after treatment. Secondary * To evaluate the time to tumor progression in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide. * To evaluate and document toxicities from the administration of temozolomide combined with radiotherapy and to further study any toxicities associated with the chronic administration of the extended low-dose temozolomide schedule in this population group. * To document radiological response to the above treatment with MR imaging and, where available, functional imaging. OUTLINE: This is a multicenter study. * Chemoradiotherapy: Patients receive oral temozolomide once daily for 6 weeks (7 days per week) with concurrent radiotherapy (5 days per week). Patients without evidence of disease progression proceed to maintenance therapy beginning at least 4 weeks after completion of radiotherapy. * Maintenance therapy: Patients receive oral temozolomide daily on days 1-21. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to chemoradiotherapy and prior to course 1 of adjuvant temozolomide and prior to every 3 subsequent courses of adjuvant temozolomide. After completion of study therapy, patients are followed every 8 weeks.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	motexafin gadolinium
DRUG	temozolomide
PROCEDURE	adjuvant therapy
PROCEDURE	quality-of-life assessment
RADIATION	radiation therapy

Timeline

• Start date: 2008-01-01
• First posted: 2007-08-09
• Last updated: 2013-08-12

Locations

21 sites across 2 countries: Ireland, United Kingdom