The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors|
- Feasibility of treating pediatric patients with CNS radiation necrosis with bevacizumab [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
Outcome 1: We will monitor overall neurologic status and symptoms before, during and 1 month following treatment with bevacizumab.
Outcome 2: The 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: We will also follow changes in neuro-imaging through MRI which will include Mass Resonance Spectroscopy (MRS).
Outcome 4: We will evaluate quality of life using a comprehensive multi-attribute health status classification system developed by a group at McMasters University.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201850
|Contact: Margaret Macy, M.D.||720-777-8856||Margaret.Macy@Childrenscolorado.org|
|Contact: Debra Schissel, R.N.||720.777.2879||Debra.Schissel@Childrenscolorado.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Margaret Macy, M.D. 720-777-8856 Margaret.Macy@Childrenscolorado.org|
|Contact: Debra Schissel, R.N. 720.777.2879 Debra.Schisssel@Chihldrenscolorado.org|
|Principal Investigator: Margaret Macy, MD|
|Principal Investigator:||Margaret Macy, MD||Children's Hospital Colorado|