Clinical trial NCT01743950: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Glioma
Keywords: Glioblastoma
anaplastic glioma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: National Cancer Institute (NCI)
First posted: 2012-12-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: end of study, which will be an average of 12 months
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: up to 30 days post last dose of bevacizumab
measure: Incidence of Late Toxicities
timeFrame: from 90 days post radiotherapy until time of death
measure: progression free survival
timeFrame: at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients
measure: Change in Mini Mental State Exam (MMSE) Score
timeFrame: baseline and then approximately every 8 weeks for 18 months
measure: Change in Participant Reported FACT-BR Score
timeFrame: baseline and then approximately every 8 weeks for 18 months
measure: Change in Participant Reported FACIT-F Score
timeFrame: baseline and then approximately every 8 weeks for 18 months
measure: Change in Karnofsky Performance Status
timeFrame: baseline and then approximately every 8 weeks for 18 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Steve Howard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: H. Ian Robins, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: