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Radiosurgery and Avastin for Recurrent Malignant Gliomas

18 Years
80 Years
Not Enrolling
Malignant Glioma

Thank you

Trial Information

Radiosurgery and Avastin for Recurrent Malignant Gliomas

In this pilot study, 15 human subjects with recurrent, unifocal malignant gliomas up to 5-cm
in maximum dimension no longer responding to conventional chemotherapy but able to tolerate
further chemotherapy will be enrolled. The primary endpoint of this study will be the
proportion of patients who experience CNS toxicity, with secondary endpoints
progression-free survival, overall survival, steroid dosage, development of radionecrosis,
quality of life, objective radiographic response and performance status.

Inclusion Criteria:

- History of malignant glioma (WHO Grade III or IV) of the brain treated with some
combination of surgery, biochemotherapy and conventionally fractionated external beam

- Radiotherapy completed at least 6 months prior to recurrence

- Age 18 years and older

- New or enlarging contrast-enhancing and/or 18FDG-avid nodule, at least 1 cm diameter

- Estimated life expectancy of 3 months or longer

Exclusion Criteria:

- Avastin therapy within 21 days of start of participation

- Contraindication to Avastin therapy or brain MRI

- Presence of bleeding diathesis or coagulopathy

- History of prior arterial thrombotic event, myocardial infarction, angina, CVA, TIA,
CABG angioplasty or stenting within 6 months.

- Inadequately controlled hypertension (defined as systolic blood pressure

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Clinically significant vascular disease

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to onset of treatment

- Prior history of hypertensive crisis or hypertensive encephalopathy

- History of abdominal fistula or GI perforation within 6 months prior to onset of

- Serious non-healing wound, active ulcer or untreated bone fracture

- Proteinuria demonstrated by Urine Protein Creatinine ratio > 1.0

- Pregnancy

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Central Nervous System (CNS) Toxicity

Outcome Description:

Grade 3 or higher adverse event in the "Nervous System Disorder" domain of CTCAE v4.0. CNS hemorrhage is the primary toxicity to assess.

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

John Kirkpatrick, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

December 2009

Completion Date:

February 2012

Related Keywords:

  • Malignant Glioma
  • Recurrent
  • Glioma



Duke University Medical Center, Radiation Oncology Durham, North Carolina  27710