Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-26 @ 9:09 AM
Study NCT ID:
NCT01201850
Status:
TERMINATED
Last Update Posted:
2021-05-19
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: