Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme
Multicenter Phase II Study of Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Multiforme
1 other identifier
interventional
16
1 country
1
Brief Summary
This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to the tumor bed border zone in conjunction with the usage of bevacizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedResults Posted
Study results publicly available
April 25, 2019
CompletedMay 7, 2019
April 1, 2019
3.9 years
January 10, 2014
April 2, 2019
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
The number of months that a patient remains alive from the day first gamma knife surgery until the date of death or end of data collection for survival.
Up to 2 years
Secondary Outcomes (14)
6-month Progression-free Survival
At 6 months
6-month Overall Survival
At 6 months
CNS Toxicity
Six months after SRS
Tumor Response
Up to 2 years
Potential Value of Magnetic Resonance Spectroscopy (MRS)
Prior to radiosurgery
- +9 more secondary outcomes
Study Arms (1)
BZ-SRS with Bevacizumab
EXPERIMENTALAll patients will receive Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS
Interventions
Patients will receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by10 mg/kg/day every 14 days until progression.
Subjects will have MRS prior to BZ-SRS.
The 'border zone' of the tumor will be targeted by SRS in a single session.
Eligibility Criteria
You may qualify if:
- Histologically confirmed glioblastoma multiforme, WHO grade IV astrocytoma.
- Prior first-line treatment with surgery or biopsy followed by fractionated radiotherapy with concurrent temozolomide-containing chemotherapy is required for glioblastoma patients. Additional prior chemotherapy is allowed, without limitation on number of recurrences.
- An interval of at least 2 months since completion of fractionated radiotherapy.
- Age \> 18 years
- Life expectancy of at least 12 weeks.
- Karnofsky Performance Status score (KPS) of ≥ 60
- Documented recurrent disease; Disease must be evaluable, but does not need to be measurable; the target site for SRS does not need to be located in a previously-irradiated area.
- All patients must have no restrictions to obtaining MRI with and without gadolinium contrast.
- Adequate bone marrow, hepatic and renal function ; BUN \< 25 and Cr \< 1.7
- Negative pregnancy test at the time of SRS in any patient who could be pregnant.
- Willingness to forego additional therapy until evidence of disease progression
You may not qualify if:
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last 3 years.
- Prior radiosurgery
- Prior intracavitary irradiation or Gliadel wafers.
- Inability to comply with protocol or study procedures
- Prior treatment with bevacizumab.
- Inability to undergo MRI with and without contrast administration.
- Inadequately controlled hypertension.
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or unstable angina within 6 months prior to Day 1.
- History of stroke or transient ischemic attack within 6 months prior to Day 1.
- Significant vascular disease within 6 months prior to Day 1.
- History of hemoptysis within 1 month prior to Day 1.
- Evidence of bleeding diathesis or significant coagulopathy
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ajay Niranjanlead
- Genentech, Inc.collaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara Stadterman
- Organization
- UPMC Hillman Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ajay Niranjan, MD
University of Pittsburgh Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 10, 2014
First Posted
April 22, 2014
Study Start
May 1, 2014
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
May 7, 2019
Results First Posted
April 25, 2019
Record last verified: 2019-04