NCT01392209

Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma

A PHASE I DOSE ESCALATION STUDY OF HYPOFRACTIONATED STEREOTACTIC RADIOTHERAPY WITH BEVACIZUMAB IN THE TREATMENT OF RECURRENT MALIGNANT GLIOMA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The best dose of radiation to be given with bevacizumab is currently unknown. This study will use higher doses of radiation with bevacizumab than have been used before. This study will test the safety of radiation given at different doses with bevacizumab to find out what effects, good and/or bad, it has on the patient and the malignant glioma or related brain cancers.

Conditions

• Brain Cancer
• MALIGNANT GLIOMA
• Glioblastoma
• Anaplastic Astrocytoma (AA)
• Anaplastic Oligodendroglioma (AO)
• Anaplastic Oligo-astrocytoma (AOA)
• Anaplastic Mixed Gliomas
• Malignant Glioma NOS

Interventions

Type	Name	Description
OTHER	Bevacizumab & Stereotactic Radiotherapy	Treatment: (until treatment failure): bevacizumab 10 mg/kg IV once every two weeks on days 1 (+/- 3 days) and 15 (+/- 3 days) of every cycle (Cycle defined as 28 days). On day 28 (or up to 2 days before) of cycles 1 and 2 (and for every other cycle thereafter) patients will undergo a physical and radiological re-evaluation (MRI). Patients will begin stereotactic radiotherapy beginning anywhere from day 7 to day 10 of cycle 2 with escalating fraction sizes (interpatient - there is no intrapatient escalation). Assessment of response will be performed following cycles 1 and 2 then following every two cycles.

Timeline

• Start date: 2011-07-08
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2011-07-12
• Last updated: 2019-11-22

Locations

5 sites across 1 country: United States