NCT01201850

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment Plan: For patient consented and enrolled on study, bevacizumab will be administered at a dose of 10 mg/kg IV every 2 weeks for a total of 6 doses (3 doses/cycle). Patients are expected to receive at least 1 cycle (6 weeks) of study treatment unless an unacceptable drug reaction occurs. Patients will receive a second cycle of treatment as long as treatment is tolerated. Response assessment will be performed every 6 weeks (three doses/cycle of study drug) including clinical and radiological assessment. Secondary measures including documentation of total equivalent steroid dose, length of time on steroids, and quality of life using the modified McMaster Health Instrument scale will also be collected while on treatment and 30 days after finishing treatment. Safety will be assessed by routine physical and laboratory evaluations. Adverse events will be recorded and the severity graded according to the NCI Common Terminology Criteria for Adverse Events (version 4.0).

Conditions

• Radiation Necrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-06-28
• Primary completion: 2016-08-04
• Completion: 2016-08-04
• First posted: 2010-09-15
• Last updated: 2021-05-19
• Results posted: 2021-04-29

Locations

1 site across 1 country: United States