Clinical Trials Office

ACNS0821: Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial

What is the purpose of this study?

This randomized phase II trial is studying how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or CNS primitive neuroectodermal tumors.

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

Conditions

  • Cancer - Brain and Spinal Tumors
  • Medications
  • Neurology

What is involved?

This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I
Patients receive oral temozolomide and irinotecan hydrochloride IV over 90 minutes on days 1-5.

Arm II
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.

Who should I contact for more information?

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799 
cancer@cchmc.org

Where can I find additional information?