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

Radiation Necrosis Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Necrosis
• Nervous System Neoplasms
• Radiation Necrosis

• NCT number: NCT01201850
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Terminated
• Phase: N/A
• Start date: June 28, 2010
• Completion date: August 4, 2016