Who can participate?
Diagnosis of medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy
- Patients must have experienced at least one and at most two relapses prior to study enrollment
- Patients with primary refractory disease are eligible
- Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence
- Patients must have measurable residual disease, defined as tumor that is measurable in two perpendicular diameters on MRI
- Diffuse leptomeningeal disease is not considered measurable
- All patients must have a brain MRI with and without gadolinium and a spine MRI with gadolinium performed within 2 weeks prior to study enrollment
- Patients must not have evidence of new CNS hemorrhage on baseline MRI
What will happen in the study?
This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients receive oral temozolomide and irinotecan hydrochloride IV over 90 minutes on days 1-5.
Patients receive oral temozolomide and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.