Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02775 | Registry Identifier | NCI Trial ID | |
| 2012-0648 | Other Identifier | Institutional Review Board | |
| 2017-0683 | Other Identifier | Institutional Review Board | |
| A533300 | Other Identifier | UW Madison | |
| SMPH\HUMAN ONCOLOGY\HUMAN ONCO | Other Identifier | UW Madison | |
| Protocol Version 10/14/2020 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 10mg/kg every 2weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | time of first dose of PRDR+ Bevacizumab until time of death | estimated to be an average of 12 months (the estimated mean follow-up time) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | data collected up to 18 months |
| Incidence of Late Toxicities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steve Howard, MD | University of Wisconsin, Madison | Principal Investigator |
| H. Ian Robins, MD, Ph.D | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
Not provided
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
Not provided
Not provided
Participants were enrolled from July 2013 to May 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab-naïve With 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | time of first dose of PRDR+ Bevacizumab until time of death | Posted | Median | Standard Deviation | months | estimated to be an average of 12 months (the estimated mean follow-up time) |
|
Data collected up to approximately 18 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab-naïve With Recurrent IDH Wildtype High Grade Glioma | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v4.0 | Non-systematic Assessment |
Study was terminated early per slow accrual and is underpowered for meaningful interpretation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Morris, MD, PhD | University of Wisconsin - Madison | (608) 265-5094 | bmorris@humonc.wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2023 | Oct 9, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069475 | Re-Irradiation |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PRDR | Radiation | 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. |
|
|
Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded. |
| 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. | 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. | 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. | 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. | 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. | baseline and then approximately every 2 months for up to 10 months (data was not collected from participants after 10 months) |
| Physician Decision |
|
| Death |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Bevacizumab-naïve With Recurrent IDH Mutant Glioma |
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression |
| OG003 | Bevacizumab-exposed With Recurrent IDH Mutant Glioma | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | data collected up to 18 months |
|
|
|
| Secondary | Incidence of Late Toxicities | Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded. | Posted | Count of Participants | Participants | data collected up to 18 months |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | months | estimated to be an average of 12 months (the estimated mean follow-up time) |
|
|
|
| Secondary | 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. | Many participants refused to complete surveys and therefore data does not exist for all time points and for all arms. | Posted | Mean | Standard Deviation | score on a scale | data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months) |
|
|
|
| Secondary | 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. | Many participants refused to complete surveys and therefore data does not exist for all time points and for all arms. | Posted | Mean | Standard Deviation | score on a scale | data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months) |
|
|
|
| Secondary | 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. | Many participants refused to complete surveys and therefore data does not exist for all time points and for all arms. | Posted | Mean | Standard Deviation | score on a scale | data collected baseline and then approximately every 2 months for 8 months (participants did not provide data after 8 months) |
|
|
|
| Secondary | 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. | Follow up data not collected due to disease progression. | Posted | Mean | Standard Deviation | score on a scale | baseline and then approximately every 2 months for up to 10 months (data was not collected from participants after 10 months) |
|
|
|
| 7 |
| 9 |
| 0 |
| 9 |
| 5 |
| 9 |
| EG001 | 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 | 34 | 37 | 2 | 37 | 31 | 37 |
| EG002 | Bevacizumab-naïve With Recurrent IDH Mutant Glioma | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression | 1 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Bevacizumab-exposed With Recurrent IDH Mutant Glioma | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression | 2 | 2 | 1 | 2 | 1 | 2 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Radiation Dermatitis | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Taste Changes | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Memory Impairment | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Muscle Weakness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Cognitive Disturbance | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nose Bleed | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Voice Changes | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gait Disturbance | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Extremity Weakness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Decreased Apetite | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Dysphasia | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Edema | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Central Nervous System Necrosis | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Oral Hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Erythema multiforme | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D019233 | Retreatment |
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
|
| last day of Radiation Therapy (up to approximately 6 weeks) |
|
|
| 2 months |
|
|
| 4 months |
|
|
| 6 months |
|
|
| 8 months |
|
|
|
| Last day of Radiation Therapy (up to approximately 6 weeks) |
|
|
| 2 months |
|
|
| 4 months |
|
|
| 6 months |
|
|
| 8 months |
|
|
|
| Last Day of Radiation Therapy (up to approximately 6 weeks) |
|
|
| 2 months |
|
|
| 4 months |
|
|
| 6 months |
|
|
| 8 months |
|
|
|
| 1 month post treatment |
|
|
| 2 months |
|
|
| 4 months |
|
|
| 6 months |
|
|
| 8 months |
|
|
| 10 months |
|
|