GliomaPhase 2NCT01743950
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
A Phase 2 study testing Bevacizumab and PRDR in people with Glioma, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Bevacizumab and PRDR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2012to 24 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
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
- Glioma
- Being tested
- Bevacizumab, PRDR
- Keywords
- Glioblastoma, anaplastic glioma
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
10mg/kg every 2weeks.
PRDRRadiation
Also called re-irradiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab-naïve with recurrent IDH wildtype high grade glioma | Active comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression Receives: Drug: Bevacizumab; Radiation: PRDR |
| Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma | Active comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression Receives: Drug: Bevacizumab; Radiation: PRDR |
| Bevacizumab-naïve with recurrent IDH mutant glioma | Active comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression Receives: Drug: Bevacizumab; Radiation: PRDR |
| Bevacizumab-exposed with recurrent IDH mutant glioma | Active comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression Receives: Drug: Bevacizumab; Radiation: PRDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
time of first dose of PRDR+ Bevacizumab until time of death
Measured: estimated to be an average of 12 months (the estimated mean follow-up time)
Secondary outcomes (7)
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.
Measured: data collected up to 18 months
Incidence of Late Toxicities
Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.
Measured: data collected up to 18 months
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.
Measured: estimated to be an average of 12 months (the estimated mean follow-up time)
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.
Measured: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 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.
Measured: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)
Change in Participant Reported FACIT-F Score
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.
Measured: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)
Change in Karnofsky Performance Status
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.
Measured: baseline and then approximately every 2 months for up to 10 months (data was not collected from participants after 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start3 Dec 2012
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steve Howard, MD, Principal investigator, University of Wisconsin, MadisonH. Ian Robins, MD, Ph.D, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743950
- Sponsor's protocol ID
- 2017-0683
- Other IDs
- NCI-2012-02775, 2012-0648, 2017-0683, A533300, SMPH\HUMAN ONCOLOGY\HUMAN ONCO, Protocol Version 10/14/2020
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2012
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
- ClinicalTrials.gov ID
- NCT01743950
- Acronym / sponsor ID
- 2017-0683
- Conditions
- Glioma
- Keywords
- Glioblastoma, anaplastic glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Genentech, Inc., National Cancer Institute (NCI)
- Study start
- 3 Dec 2012 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab-naïve with recurrent IDH wildtype high grade glioma | Active comparator | Drug: Bevacizumab, Radiation: PRDR27fractions 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 | Active comparator | Drug: Bevacizumab, Radiation: PRDR27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression |
| Bevacizumab-naïve with recurrent IDH mutant glioma | Active comparator | Drug: Bevacizumab, Radiation: PRDR27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression |
| Bevacizumab-exposed with recurrent IDH mutant glioma | Active comparator | Drug: Bevacizumab, Radiation: PRDR27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab10mg/kg every 2weeks. | Drug | Bevacizumab-exposed with recurrent IDH mutant glioma, Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma, Bevacizumab-naïve with recurrent IDH mutant glioma, Bevacizumab-naïve with recurrent IDH wildtype high grade glioma |
| PRDRAlso: re-irradiationDaily 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. | Radiation | Bevacizumab-exposed with recurrent IDH mutant glioma, Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma, Bevacizumab-naïve with recurrent IDH mutant glioma, Bevacizumab-naïve with recurrent IDH wildtype high grade glioma |
Primary outcome
Overall Survival
Time frame: 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
7 secondary outcomes
Incidence of Adverse Events
Time frame: data collected up to 18 months
Incidence of Late Toxicities
Time frame: data collected up to 18 months
Progression Free Survival
Time frame: estimated to be an average of 12 months (the estimated mean follow-up time)
Change in Mini Mental State Exam (MMSE) Score
Time frame: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)
Change in Participant Reported FACT-BR Score
Time frame: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)
Change in Participant Reported FACIT-F Score
Time frame: data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months)
Change in Karnofsky Performance Status
Time frame: baseline and then approximately every 2 months for up to 10 months (data was not collected from participants after 10 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Howard, MD principal investigator
University of Wisconsin, Madison
H. Ian Robins, MD, Ph.D principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and PRDR in people with Glioma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: estimated to be an average of 12 months (the estimated mean follow-up time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.