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The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors

NCT01201850 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-05-19

Study results available
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Summary

This study is being done to learn about the safety of the study drug bevacizumab(Avastin®), when used to treat radiation necrosis.

The primary objective of this study is to test the feasibility of treating Central Nervous System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2 weeks.

The secondary objectives of this study are:

* To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed by clinical evaluation;
* To investigate the neuro-imaging changes in radiation necrosis associated edema, including Mass Resonance (MR) spectroscopy;
* To evaluate changes in corticosteroid use in patients with radiation necrosis following treatment with bevacizumab;
* To evaluate changes in quality of life.

Conditions

Interventions

DRUG

Bevacizumab (Avastin®)

Once enrolled on study, patients will be treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses. An MRI will be done after the first cycle (3 doses/ 6weeks) and then again at the end of therapy.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Margaret Macy, MD · Children's Hospital Colorado

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-28
Primary Completion
2016-08-04
Completion
2016-08-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01201850 on ClinicalTrials.gov