Trial Information

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

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.