Glioma
Conditions
Keywords
Glioblastoma, anaplastic glioma
Brief 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.
Interventions
DRUGBevacizumab
10mg/kg every 2weeks.
RADIATIONPRDR
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
University of Wisconsin, Madison
Genentech, Inc.
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | data collected up to 18 months | 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. |
| Incidence of Late Toxicities | data collected up to 18 months | Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded. |
| Progression Free Survival | 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. |
| Change in Mini Mental State Exam (MMSE) Score | data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months) | 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. |
| Change in Participant Reported FACT-BR Score | data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months) | 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. |
| Change in Participant Reported FACIT-F Score | data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months) | 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. |
| Change in Karnofsky Performance Status | baseline and then approximately every 2 months for up to 10 months (data was not collected from participants after 10 months) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteve Howard, MD
University of Wisconsin, Madison
PRINCIPAL_INVESTIGATORH. Ian Robins, MD, Ph.D
University of Wisconsin, Madison
Participant flow
Recruitment details
Participants were enrolled from July 2013 to May 2023.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 20-29 years | 1 Participants |
| Age, Customized 30-39 years | 6 Participants |
| Age, Customized 40-49 years | 7 Participants |
| Age, Customized 50-59 years | 18 Participants |
| Age, Customized 60-69 years | 14 Participants |
| Age, Customized 70-79 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 9 | 34 / 37 | 1 / 1 | 2 / 2 |
| other Total, other adverse events | 5 / 9 | 31 / 37 | 0 / 1 | 1 / 2 |
| serious Total, serious adverse events | 0 / 9 | 2 / 37 | 0 / 1 | 1 / 2 |
Outcome results
None listed