A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

Phase 2TerminatedNCT01743950

University of Wisconsin, Madison49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioma

Interventions

BevacizumabDRUG

10mg/kg every 2weeks.

PRDRRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or molecularly confirmed Grade 3 or 4 glioma, IDH mutant or wildtype, as defined by the 2021 WHO guidelines * Recurrent disease based on combination of clinical, imaging or histologic confirmation * Must have previously received radiation and temozolomide to treat their glioma * Bevacizumab naive patients must be \> 5 months post completion of initial radiation therapy * Bevacizumab exposed patients must be \> 3 months post completion of initial radiation therapy * Age must be \>18years, KPS must be greater than 60 * Hematology, chemistry and a urinalysis must meet protocol specified criteria Exclusion Criteria: * Pregnant or breastfeeding * Uncontrolled hypertension (\>160/90mmHg) * Prior malignancy unless treated \>1 year prior to study and have been without treatment and disease free for 1 yr * active second malignancy unless non-melanoma skin cancer or cervical cancer in situ

Locations (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Overall survival

time of first dose of PDRD+ Bevacizumab until time of death

Time frame: end of study, which will be an average of 12 months

Secondary Outcomes

Incidence of Adverse Events

time of first dose of PDRD+ Bevacizumab until time of death. All changes from baseline assessment will be recorded until 30 days post last dose of bevacizumab, assessed using the NCI CTCAE version 4.0 criteria.

Time frame: up to 30 days post last dose of bevacizumab

Incidence of Late Toxicities

Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.

Time frame: from 90 days post radiotherapy until time of death

progression free survival

Progression free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of disease progression or death.

Time frame: at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients

Change in Mini Mental State Exam (MMSE) Score

The MMSE survey is a clinician facilitated instrument scored on a scale of 0-30 where scores of 0-17 indicate severe cognitive impairment, 18-23 indicate mild cognitive impairment, and 24-30 indicate no cognitive impairment.

Time frame: baseline and then approximately every 8 weeks for 18 months

Change in Participant Reported FACT-BR Score

The Functional Assessment of Cancer Therapy - Brain (FACT-BR) instrument is a 50-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is 0-200 where higher scores indicate higher quality of life.

Data from ClinicalTrials.gov

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