A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

Glioma Clinical Trial

Official title:

A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01743950
• Other study ID #: CO11374
• Secondary ID: NCI-2012-0277520
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 3, 2012
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• Bevacizumab
10mg/kg every 2weeks.

Radiation:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Genentech, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	time of first dose of PDRD+ Bevacizumab until time of death	end of study, which will be an average of 12 months
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.	up to 30 days post last dose of bevacizumab
Secondary	Incidence of Late Toxicities	Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.	from 90 days post radiotherapy until time of death
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.	at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients
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.	baseline and then approximately every 8 weeks for 18 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.	baseline and then approximately every 8 weeks for 18 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.	baseline and then approximately every 8 weeks for 18 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.	baseline and then approximately every 8 weeks for 18 months

External Links

•   University of Wisconsin Carbone Cancer Center