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:
P30CA014520
- SECONDARY ID:
NCI-2012-02775
- SECONDARY ID:
2012-0648
- SECONDARY ID:
2017-0683
- NCT ID:
NCT01743950
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Bevacizumab | | Bevacizumab naive recurrent grade IV 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: | safety profile |
Time Frame: | assessed every two weeks prior to each bevacizumab infusion while on treatment then 30 post completion of therapy |
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. In addition any late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded. |
Measure: | progression free survival |
Time Frame: | at 3months for bevacizumab exposed patients, at 6 and 12 months for all patients |
Safety Issue: | |
Description: | will be determined based on clinical and radiographic evidence |
Measure: | neurologic changes |
Time Frame: | baseline and then approximately every 8 weeks for 18 months |
Safety Issue: | |
Description: | will be assessed by physician with mini-mental exam and a FACT BR completed by the patient |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Wisconsin, Madison |
Trial Keywords
- Glioblastoma
- anaplastic glioma
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