CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
Bevacizumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01217437
NCT01217437Phase 2Completed

Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, a COG Randomized Phase II Screening Trial

National Cancer Institute (NCI)·interventional·Posted Oct 8, 2010·Updated Jul 23, 2021

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Irinotecan Hydrochloride, and 1 other intervention for Central Nervous System Neoplasm and 5 related conditions. Completed, enrolled 108 participants across 158 sites in 5 countries.

Detailed Summary

This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2010
Enrollment StartNov 22, 2010
Primary CompletionDec 31, 2017
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 15.7 years ago

Interventions

Bevacizumabbiological

Given IV

Irinotecan Hydrochloridedrug

Given IV

Temozolomidedrug

Given PO