NCT01017250

Radiosurgery and Avastin for Recurrent Malignant Gliomas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the central nervous system (CNS) toxicity in patients with recurrent malignant gliomas treated with concurrent Avastin and stereotactic radiosurgery (SRS).

Detailed description

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.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery (SRS)	Tumor Volume \< 2.0cm receives 24 Gy in 1 fraction Tumor Volume 2.0-2.9cm receives 18 Gy in 1 faction Tumor Volume 3.0-4.9cm receives 25 Gy in 5Gy/fraction
DRUG	Bevacizumab	Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-03-01
• Completion: 2012-02-01
• First posted: 2009-11-20
• Last updated: 2014-02-28
• Results posted: 2012-05-09

Locations

1 site across 1 country: United States