MedTrace Logo

Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

NCT01217437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-07-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Central Nervous System Neoplasm
  • Pineoblastoma
  • Recurrent Medulloblastoma
  • Recurrent Primitive Neuroectodermal Tumor
  • Refractory Medulloblastoma
  • Refractory Peripheral Primitive Neuroectodermal Tumor

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Adam S Levy · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-22
Primary Completion
2017-12-31
Completion
2021-06-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217437 on ClinicalTrials.gov