Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

NCT01730950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2022-12-29

Study results available
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Summary

This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. 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 cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma

Conditions

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor

Interventions

BIOLOGICAL

bevacizumab

Staring within 14 days of randomization, IV 10mg/kg every two weeks until disease progression.

RADIATION

radiation therapy

Starting with second dose of bevacizumab, 35 Gy in 10 fractions of 3.5 Gy each delivered on consecutive treatment days (typically 5 fractions per week).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Christina Tsien · Washington University School of Medicine

  • Jeffrey Raizer, MD · Northwestern University

  • Adam P. Dicker, MD, PhD · Jefferson Medical College of Thomas Jefferson University

  • Martha M. Matuszak, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-20
Primary Completion
2018-09-03
Completion
2022-12-22

Countries

  • United States

Study Locations

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Entities

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 NCT01730950 on ClinicalTrials.gov