A single intra-arterial dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.

Radiation Necrosis

Route of administration:
In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.

25% Mannitol

Route of administration:
In this study, the second step of the treatment will be administering intra-arterial bevacizumab into the appropriate cervical artery.

Low-dose Intra-arterial Bevacizumab

University of Kentucky Medical Center

Norton Brownsboro Hospital

Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI)

Imaging response to therapy will be quantitatively assessed on MRI using volumetric analysis. Regions of T2 and FLAIR prolongation above contralateral white matter will be calculated and quantified in cubic centimeters. Region of interest (ROI) will be created using a semi-automated, thresholding and region-growing technique. Enhancement of the lesion will be calculated using similar volumetric ROI analysis with a contrast threshold of 40% above background and measured in cubic centimeters.

To assess the utility of intra-arterial bevacizumab treatment in allowing decreased steroid usage, the quantity of steroid use (measured as mg of decadron per day) will be documented.

Quantitative improvement in headache will be assessed by performing the Headache Impact Test (HIT-6), which is a fixed-length 6-item questionnaire. The score for this questionnaire can range from 36 to 78, with higher scores indicating worse headache burden.

We will determine how severely headache affect the patient's life before and after treatment by performing the MIDAS 5-item questionnaire: Score of 0 to 5 signifies little or no disability, score of 6 to 10, signifies mild disability, score of 11 to 20 signifies moderate disability, and score of 21+ signifies severe disability.

In order to investigate the immediate and post-operative neurocognitive sequelae of intra-arterial bevacizumab, patients who consent to a formal neuropsychological battery will be tested. Subtests from the NAB (Neuropsychological Assessment Battery, Stern & White, PAR Inc.) have been chosen for brevity, sensitivity, and due to the wide range of available normative data (ages 18-97). In addition, the Wechsler Test of Adult Reading (WTAR, Pearson Inc.) will be administered to provide an estimate of premorbid cognitive functioning.

Safety of intra-arterial bevacizumab will be assessed by noting the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Objective improvement in neurological exam will be assessed by performing serial neurological exams.

Quantitative improvement in functional status will be assessed by performing Karnofsky Performance Status Scale (KPS). The KPS score can range from 0 to 100.

Quantitative improvement in quality of life will be assessed by performing CDC HRQOL-14 "Healthy Days Measure." This survey contains 14 items to measure health-related quality of life. It consists of three modules: the 4-item Healthy Days Core Module (CDC HDQOL-4), 5-item Activity Limitations Module, and 5-item Healthy Days Symptom Module. The items in this survey are either subjective and require yes/no answer, or they involve the number of days during the past 30 days that the patient had problems secondary to different physical or mental health issues.

Cost analysis of a single treatment of low dose intra-arterial bevacizumab after osmotic blood-brain-barrier disruption as compared to conventional intravenous bevacizumab use for radiation necrosis (7.5 mg/kg IV-Bevacizumab every 3 weeks for 4 cycles)

Shervin Dashti, MD

Principal Investigator

Norton Healthcare

University of Kentucky

Brain Tumor, Recurrent

Glioblastoma Multiforme

In this study we had intended to perform a similar dose escalation study with doses ranging from 10-19 Gy, 10-16 Gy and 10 - 14 Gy for tumors < 20 mm, 21-25 mm and 26-40 mm respectively

Photon Radiosurgery System (Intrabeam)

Children's Memorial Hospital

A Phase I/II Study of the Photon Radiosurgery System

A Phase I/II Study of Reirradiation for Recurrent Pediatric Brain and Spinal Cord Tumors and Primary Glioblastoma Multiforme Using the Photon Radiosurgery System

ependymoma/phù nề

Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI)

A Phase I/II Study of the Photon Radiosurgery System

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