Back to resultsA Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
Primary Purpose
Glioma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
PRDR
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring Glioblastoma, anaplastic glioma
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Bevacizumab-naïve with recurrent IDH wildtype high grade glioma
Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma
Bevacizumab-naïve with recurrent IDH mutant glioma
Bevacizumab-exposed with recurrent IDH mutant glioma
Arm Description
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Outcomes
Primary Outcome Measures
Overall survival
time of first dose of PDRD+ Bevacizumab until time of death
Secondary Outcome Measures
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.
Incidence of Late Toxicities
Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01743950
First Posted
November 27, 2012
Last Updated
November 14, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
Genentech, Inc., National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01743950
Brief Title
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
Official Title
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Genentech, Inc., National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
Glioblastoma, anaplastic glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab-naïve with recurrent IDH wildtype high grade glioma
Arm Type
Active Comparator
Arm Description
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Arm Title
Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma
Arm Type
Active Comparator
Arm Description
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Arm Title
Bevacizumab-naïve with recurrent IDH mutant glioma
Arm Type
Active Comparator
Arm Description
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Arm Title
Bevacizumab-exposed with recurrent IDH mutant glioma
Arm Type
Active Comparator
Arm Description
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
10mg/kg every 2weeks.
Intervention Type
Radiation
Intervention Name(s)
PRDR
Other Intervention Name(s)
re-irradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
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 Outcome Measure Information:
Title
Incidence of Adverse Events
Description
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
Title
Incidence of Late Toxicities
Description
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
Title
progression free survival
Description
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
Title
Change in Mini Mental State Exam (MMSE) Score
Description
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
Title
Change in Participant Reported FACT-BR Score
Description
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.
Time Frame
baseline and then approximately every 8 weeks for 18 months
Title
Change in Participant Reported FACIT-F Score
Description
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.
Time Frame
baseline and then approximately every 8 weeks for 18 months
Title
Change in Karnofsky Performance Status
Description
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.
Time Frame
baseline and then approximately every 8 weeks for 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Trask, BS
Phone
608-263-9528
Email
trask@humonc.wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nick Anger, BS
Phone
608-262-8649
Email
anger@humonc.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Howard, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. Ian Robins, MD, Ph.D
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Connect
Phone
800-622-8922
Email
clinicaltrials@cancer.wisc.edu
First Name & Middle Initial & Last Name & Degree
Steve Howard, MD
First Name & Middle Initial & Last Name & Degree
H. Ian Robins, MD, Ph.D
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
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