Medulloblastoma and PNET Therapies with Temozolomide, Irinotecan, and Bevacizumab – Phase II

Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial

Protocol Description

This Children’s Oncology Group clinical trial is studying effects of temozolomide and irinotecan together, provided with or without bevacizumab, in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors (PNET). The combination of temozolomide and irinotecan has been used to treat adults and children with other types of cancer. Researchers believe this combination may help in treating medulloblastoma and PNET, and would like to determine if adding bevacizumab improves outcomes.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to children and young adults, up to 21 years of age, who have a medulloblastoma or PNET that has relapsed or become refractory to standard chemotherapy.
Males and Females: Up to 21 years old

Requirements

Participants will be randomly assigned to either a group that receives temozolomide and irinotecan or one that receives this drug combination along with bevacizumab. Treatment cycles last 4 weeks and require 5 consecutive days of drug therapy followed by 23 without. After 2 cycles, participants’ tumors will be evaluated, with a determination made as to whether to remain for more cycles – potentially up to 12.
Visits: Requires monthly visits each cycle for patients receiving temozolomide irinotecan; Twice-monthly visits for patients receiving bevacizumab
Duration: Up to 48 weeks

Status: Open for Enrollment

Source(s) of Support

Children’s Oncology Group (Study ACNS0821)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Krol, RN, BSN
412-692-8864