Trial Outcomes & Findings for A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab (NCT NCT01743950)
NCT ID: NCT01743950
Last Updated: 2026-03-25
Results Overview
time of first dose of PRDR+ Bevacizumab until time of death
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
estimated to be an average of 12 months (the estimated mean follow-up time)
Results posted on
2026-03-25
Participant Flow
Participants were enrolled from July 2013 to May 2023.
Participant milestones
| Measure |
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
27fractions over 5.5weeks of Pulse Reduced Dose Rate (PRDR) radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
37
|
1
|
2
|
|
Overall Study
Off Treatment
|
9
|
34
|
1
|
2
|
|
Overall Study
On Follow Up
|
9
|
32
|
1
|
2
|
|
Overall Study
COMPLETED
|
7
|
32
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
27fractions over 5.5weeks of Pulse Reduced Dose Rate (PRDR) radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
Baseline characteristics by cohort
| Measure |
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Bevacizumab: 10mg/kg every 2weeks.
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
20-29 years
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=88 Participants
|
|
Age, Customized
30-39 years
|
1 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
6 Participants
n=88 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
7 Participants
n=88 Participants
|
|
Age, Customized
50-59 years
|
3 Participants
n=138 Participants
|
14 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
18 Participants
n=88 Participants
|
|
Age, Customized
60-69 years
|
1 Participants
n=138 Participants
|
13 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
14 Participants
n=88 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
3 Participants
n=88 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=138 Participants
|
12 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
16 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=138 Participants
|
25 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=158 Participants
|
33 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=138 Participants
|
36 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=158 Participants
|
48 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=138 Participants
|
37 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=158 Participants
|
49 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=138 Participants
|
37 participants
n=62 Participants
|
1 participants
n=123 Participants
|
2 participants
n=158 Participants
|
49 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: estimated to be an average of 12 months (the estimated mean follow-up time)time of first dose of PRDR+ Bevacizumab until time of death
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Overall Survival
|
3.6 months
Standard Deviation 1.3
|
14.47 months
Standard Deviation 6.0
|
6.73 months
Standard Deviation 4.8
|
16.2 months
|
SECONDARY outcome
Timeframe: data collected up to 18 monthstime 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.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Incidence of Adverse Events
No Adverse Events Experienced
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Incidence of Adverse Events
Grade 1
|
0 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 2
|
1 Participants
|
2 Participants
|
17 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 3
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: data collected up to 18 monthsLate toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Incidence of Late Toxicities
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: estimated to be an average of 12 months (the estimated mean follow-up time)Progression free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of disease progression or death.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Progression Free Survival
|
3.7 months
Standard Deviation 0.3
|
11 months
Standard Deviation 3.7
|
4.93 months
Standard Deviation 3.3
|
42.9 months
|
SECONDARY outcome
Timeframe: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)Population: Many participants refused to complete surveys and therefore data does not exist for all time points and for all arms.
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.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=3 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=12 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Change in Mini Mental State Exam (MMSE) Score
6 months
|
—
|
—
|
18.5 score on a scale
Standard Deviation 3.5
|
—
|
|
Change in Mini Mental State Exam (MMSE) Score
baseline (pre-treatment)
|
—
|
27.3 score on a scale
Standard Deviation 1.2
|
28 score on a scale
Standard Deviation 2.6
|
—
|
|
Change in Mini Mental State Exam (MMSE) Score
last day of Radiation Therapy (up to approximately 6 weeks)
|
—
|
26 score on a scale
|
27.1 score on a scale
Standard Deviation 3.5
|
—
|
|
Change in Mini Mental State Exam (MMSE) Score
2 months
|
—
|
27 score on a scale
|
24.7 score on a scale
Standard Deviation 7.0
|
—
|
|
Change in Mini Mental State Exam (MMSE) Score
4 months
|
—
|
24 score on a scale
|
24.3 score on a scale
Standard Deviation 3.1
|
—
|
|
Change in Mini Mental State Exam (MMSE) Score
8 months
|
—
|
—
|
18 score on a scale
|
—
|
SECONDARY outcome
Timeframe: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)Population: Many participants refused to complete surveys and therefore data does not exist for all time points and for all arms.
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.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=3 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Change in Participant Reported FACT-BR Score
baseline (pre-treatment)
|
—
|
62 score on a scale
Standard Deviation 13
|
68.3 score on a scale
Standard Deviation 11.6
|
—
|
|
Change in Participant Reported FACT-BR Score
Last day of Radiation Therapy (up to approximately 6 weeks)
|
—
|
51 score on a scale
|
64.9 score on a scale
Standard Deviation 12.9
|
—
|
|
Change in Participant Reported FACT-BR Score
2 months
|
—
|
47 score on a scale
|
54.6 score on a scale
Standard Deviation 14.1
|
—
|
|
Change in Participant Reported FACT-BR Score
4 months
|
—
|
43 score on a scale
|
53.0 score on a scale
Standard Deviation 15.4
|
—
|
|
Change in Participant Reported FACT-BR Score
6 months
|
—
|
—
|
41.0 score on a scale
|
—
|
|
Change in Participant Reported FACT-BR Score
8 months
|
—
|
—
|
37.0 score on a scale
|
—
|
SECONDARY outcome
Timeframe: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)Population: Many participants refused to complete surveys and therefore data does not exist for all time points and for all arms.
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) instrument is a 13-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 from 0-52 where higher scores indicate better quality of life. A score of less than 30 indicates severe fatigue.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=3 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=9 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Change in Participant Reported FACIT-F Score
baseline
|
—
|
140 score on a scale
Standard Deviation 27.6
|
155 score on a scale
Standard Deviation 17.7
|
—
|
|
Change in Participant Reported FACIT-F Score
Last Day of Radiation Therapy (up to approximately 6 weeks)
|
—
|
103 score on a scale
|
147 score on a scale
Standard Deviation 22.0
|
—
|
|
Change in Participant Reported FACIT-F Score
2 months
|
—
|
97 score on a scale
|
127 score on a scale
Standard Deviation 20.5
|
—
|
|
Change in Participant Reported FACIT-F Score
4 months
|
—
|
94 score on a scale
|
133 score on a scale
Standard Deviation 20.0
|
—
|
|
Change in Participant Reported FACIT-F Score
6 months
|
—
|
—
|
119 score on a scale
|
—
|
|
Change in Participant Reported FACIT-F Score
8 months
|
—
|
—
|
118 score on a scale
|
—
|
SECONDARY outcome
Timeframe: baseline and then approximately every 2 months for up to 10 months (data was not collected from participants after 10 months)Population: Follow up data not collected due to disease progression.
The Karnofsky Performance Status measures a cancer patient's ability to perform ordinary tasks. It is score from 0-100 where 0 means a person has died, less than 40 is various degrees of unable to care for oneself, 50-70 is unable to work but can care for personal needs with variable assistance, and 80-100 is able to carry on normal activity with variable symptoms of disease.
Outcome measures
| Measure |
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=4 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=33 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 Participants
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Change in Karnofsky Performance Status
8 months
|
—
|
80 score on a scale
|
60 score on a scale
Standard Deviation 0.0
|
—
|
|
Change in Karnofsky Performance Status
baseline (pre-treatment)
|
100 score on a scale
Standard Deviation 0
|
95 score on a scale
Standard Deviation 14.14
|
86.7 score on a scale
Standard Deviation 13.4
|
90 score on a scale
|
|
Change in Karnofsky Performance Status
1 month post treatment
|
90 score on a scale
Standard Deviation 14
|
80 score on a scale
Standard Deviation 25.2
|
73.5 score on a scale
Standard Deviation 13.6
|
90 score on a scale
|
|
Change in Karnofsky Performance Status
2 months
|
80 score on a scale
Standard Deviation 0
|
85 score on a scale
Standard Deviation 7.0
|
81.3 score on a scale
Standard Deviation 12.5
|
—
|
|
Change in Karnofsky Performance Status
4 months
|
65 score on a scale
Standard Deviation 21
|
80 score on a scale
|
60.0 score on a scale
Standard Deviation 15.8
|
—
|
|
Change in Karnofsky Performance Status
6 months
|
—
|
80 score on a scale
|
64.0 score on a scale
Standard Deviation 21.9
|
—
|
|
Change in Karnofsky Performance Status
10 months
|
—
|
70 score on a scale
|
60 score on a scale
Standard Deviation 14.1
|
—
|
Adverse Events
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
Serious events: 0 serious events
Other events: 5 other events
Deaths: 7 deaths
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
Serious events: 2 serious events
Other events: 31 other events
Deaths: 34 deaths
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
50.0%
1/2 • Data collected up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
Other adverse events
| Measure |
Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma
n=9 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Refractory Recurrent IDH Wildtype High Grade Glioma
n=37 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-naïve With Recurrent IDH Mutant Glioma
n=1 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Bevacizumab-exposed With Recurrent IDH Mutant Glioma
n=2 participants at risk
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
|---|---|---|---|---|
|
General disorders
Gait Disturbance
|
0.00%
0/9 • Data collected up to approximately 18 months
|
8.1%
3/37 • Number of events 3 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 2 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Extremity Weakness
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Metabolism and nutrition disorders
Decreased Apetite
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 2 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Investigations
Weight loss
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Gastrointestinal disorders
Dysphasia
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
General disorders
Edema
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 3 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 4 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Central Nervous System Necrosis
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/9 • Data collected up to approximately 18 months
|
10.8%
4/37 • Number of events 4 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Data collected up to approximately 18 months
|
8.1%
3/37 • Number of events 4 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Data collected up to approximately 18 months
|
13.5%
5/37 • Number of events 6 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Muscle Weakness
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 4 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 2 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
50.0%
1/2 • Number of events 1 • Data collected up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleed
|
11.1%
1/9 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/37 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
11.1%
1/9 • Number of events 3 • Data collected up to approximately 18 months
|
0.00%
0/37 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 4 • Data collected up to approximately 18 months
|
64.9%
24/37 • Number of events 59 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 2 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 4 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Taste Changes
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 2 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • Data collected up to approximately 18 months
|
16.2%
6/37 • Number of events 7 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Data collected up to approximately 18 months
|
5.4%
2/37 • Number of events 2 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
1/9 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/37 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Nervous system disorders
Erythema multiforme
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Data collected up to approximately 18 months
|
2.7%
1/37 • Number of events 1 • Data collected up to approximately 18 months
|
0.00%
0/1 • Data collected up to approximately 18 months
|
0.00%
0/2 • Data collected up to approximately 18 months
|
Additional Information
Brett Morris, MD, PhD
University of Wisconsin - Madison
Phone: (608) 265-5094
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place