Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme

Completed · Phase 2

Conditions studied: Glioblastoma Multiforme, Glioblastoma - Category

In brief

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.

Key facts

Study ID

NCT02120287

Run by

Ajay Niranjan

People needed

16

Starts

2014-05-01

Expected to finish

2018-03-31

Last updated by the study team

2019-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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…

• General Medical Exclusions:
• 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.
• Disease-Specific Exclusions:
• Inability to comply with protocol or study procedures
• Prior treatment with bevacizumab.
• Inability to undergo MRI with and without contrast administration.
• Bevacizumab-Specific Exclusions:
• 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
• Major surgical procedure, open biopsy, or significant traumatic injury within 14 days prior to Day 1 or anticipation of need for major non -cranial surgical procedure during the course of the study.
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1.
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1.
• Serious, non-healing wound, active ulcer, or untreated bone fracture.
• Proteinuria
• Known hypersensitivity to any component of bevacizumab
• Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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