A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
NCT01743950 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2026-03-25
Summary
To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.
Conditions
Interventions
- DRUG
-
10mg/kg every 2weeks.
- RADIATION
-
PRDR
Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
National Cancer Institute (NCI)
collaborator NIH -
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Steve Howard, MD · University of Wisconsin, Madison
-
H. Ian Robins, MD, Ph.D · University of Wisconsin, Madison
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-03
- Primary Completion
- 2024-12-24
- Completion
- 2024-12-24
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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