Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

• Overall survival [ Designated as safety issue: No ]
  
• Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods [ Designated as safety issue: No ]
  

• Toxicity, steroid usage, and radiological response [ Designated as safety issue: Yes ]
  
• Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria [ Designated as safety issue: Yes ]
  

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.