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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT01201850
Status
Terminated

Conditions

  • Radiation Necrosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab (Avastin®) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 15, 2010
Start date
Jun 28, 2010
Status verified
Apr 2021
Primary completion
Aug 4, 2016
Completion
Aug 4, 2016

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of Participants Who Received at Least 5 of the 6 Scheduled Doses of Bevacizumab [ Time Frame: 13 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, CO

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