The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous System Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Bevacizumab (Avastin®)
- Conditions
- Radiation Necrosis
- Sponsor
- University of Colorado, Denver
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Received at Least 5 of the 6 Scheduled Doses of Bevacizumab
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 1 and \< 25 years of age at diagnosis
- •Interval from radiation therapy at least 4 weeks and no more than 1 year
- •Neurologic deterioration (long tract signs, cranial nerve signs or ataxia) consistent with radiation necrosis
- •MRI imaging with findings consistent with radiation necrosis as confirmed by the study radiologist
- •Craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of study entry
- •More than 28 days elapsed from the last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity)
- •Lansky or Karnofsky performance \> 40%
- •Patients may be on steroids at study entry
- •Adequate organ function defined as:
- •Peripheral absolute neutrophil (ANC) \>/= 1000/units/Liter(uL)
Exclusion Criteria
- •Disease-Specific Exclusions
- •Evidence of recent (less than 2 weeks) hemorrhage on postoperative MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumour are permitted entry into the study.
- •General Medical Exclusions
- •Subjects meeting any of the following criteria are ineligible for study entry:
- •Inability to comply with study and/or follow-up procedures
- •Life expectancy of less than 12 weeks
- •Patients who have had chemotherapy within three (3) weeks or radiation within four (4) weeks. Patients may not receive additional chemotherapeutic agents while on this study.
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- •Active second malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years.
- •Bevacizumab-Specific Exclusions
Arms & Interventions
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.
Intervention: Bevacizumab (Avastin®)
Outcomes
Primary Outcomes
Number of Participants Who Received at Least 5 of the 6 Scheduled Doses of Bevacizumab
Time Frame: 13 weeks
This pilot study was designed to evaluate the feasibility of treating pediatric patients with CNS radiation necrosis with bevacizumab. Patients enrolled on study were assessed for number of doses of bevacizumab that they received while on study. Participants who successfully received at least 5 of the 6 planned doses of bevacizumab (IV every 2 weeks) without significant events were determined to have met the outcome measure.
Secondary Outcomes
- Changes in Quality of Life With Bevacizumab Treatment(13 weeks)
- Neurologic Status With Bevacizumab Treatment(13 weeks)
- Corticosteroid Usage With Bevacixumab Treatment(13 weeks)
- Number of Patients With Changes in Neuro-Imaging With Bevacizumab Treatment(13 weeks)