Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CO11374
- SECONDARY ID:
NCI-2012-02775
- SECONDARY ID:
2012-0648
- SECONDARY ID:
2017-0683
- SECONDARY ID:
A533300
- SECONDARY ID:
SMPH\HUMAN ONCOLOGY\HUMAN ONCO
- SECONDARY ID:
Protocol Version 1/8/2020
- NCT ID:
NCT01743950
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Bevacizumab | | Bevacizumab exposed and refractive grade III gliomas |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Bevacizumab naive recurrent grade IV gliomas | Active Comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression | |
| Bevacuzumab exposed and refractive grade IV gliomas | Active Comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression | |
| Bevacizumab naive recurrent grade III gliomas | Active Comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression | |
| Bevacizumab exposed and refractive grade III gliomas | Active Comparator | 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnose of a grade WHO grade III or IV glioma
- 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 > 6months post completion of initial radiation
therapy
- Bevacizumab exposed patients must be > 3months 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
- May not be on full dose anti-coagulation therapy, Low molecular weight heparin is ok
- Uncontrolled hypertension (>140/90mmHg)
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | end of study, which will be an average of 12 months |
| Safety Issue: | |
| Description: | time of first dose of PDRD+ Bevacizumab until time of death |
Secondary Outcome Measures
| Measure: | Incidence of Adverse Events |
| Time Frame: | up to 30 days post last dose of bevacizumab |
| Safety Issue: | |
| 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. |
| Measure: | Incidence of Late Toxicities |
| Time Frame: | from 90 days post radiotherapy until time of death |
| Safety Issue: | |
| Description: | Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded. |
| Measure: | progression free survival |
| Time Frame: | at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients |
| Safety Issue: | |
| 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. |
| Measure: | Change in Mini Mental State Exam (MMSE) Score |
| Time Frame: | baseline and then approximately every 8 weeks for 18 months |
| Safety Issue: | |
| 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. |
| Measure: | Change in Participant Reported FACT-BR Score |
| Time Frame: | baseline and then approximately every 8 weeks for 18 months |
| Safety Issue: | |
| 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. |
| Measure: | Change in Participant Reported FACIT-F Score |
| Time Frame: | baseline and then approximately every 8 weeks for 18 months |
| Safety Issue: | |
| 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. |
| Measure: | Change in Karnofsky Performance Status |
| Time Frame: | baseline and then approximately every 8 weeks for 18 months |
| Safety Issue: | |
| 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. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | University of Wisconsin, Madison |
Trial Keywords
- Glioblastoma
- anaplastic glioma
Last Updated
October 8, 2020
