The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors
|ClinicalTrials.gov Identifier: NCT01201850|
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : September 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Radiation Necrosis||Drug: Bevacizumab (Avastin®)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors|
|Actual Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||September 2017|
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.
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.
- Feasibility of treating pediatric patients with CNS radiation necrosis with bevacizumab [ Time Frame: 13 weeks ]This pilot study is designed to evaluate the feasibility of treating pediatric patients with CNS radiation necrosis with bevacizumab. This regimen will be deemed feasible if a majority (7 out of 10) patients are able to successfully receive at least 5 of the 6 scheduled doses of bevacizumab without increase in serious adverse events as compared to patients post-radiation therapy alone.
- Collect multiple aspects of the patient's clinical status and radiologic imaging [ Time Frame: 13 weeks ]
Outcome 1: Monitor overall neurologic status and symptoms before, during and 1 month following treatment with bevacizumab.
Outcome 2: Dose and duration of corticosteroid use prior to, during, and up to 1 month following bevacizumab treatment will also be collected and evaluated.
Outcome 3: Changes in neuro-imaging through MRI which will include Mass Resonance Spectroscopy (MRS).
Outcome 4: Evaluate quality of life using a comprehensive multi-attribute health status classification system developed by a group at McMasters University.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201850
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Margaret Macy, MD||Children's Hospital Colorado|