NCT01738646

Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients

Phase II Study of Bevacizumab and Vorinostat for Recurrent WHO Grade IV Malignant Glioma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combination of bevacizumab and vorinostat.

Detailed description

There is no effective therapy for patients with recurrent glioblastoma multiforme (GBM) hence such patients remain a major unmet need in oncology. The investigators have recently demonstrated that bevacizumab (BV), a humanized monoclonal antibody against vascular endothelial growth factor, has significant anti-tumor activity among recurrent glioblastoma multiforme patients. Vorinostat has modest anti-tumor activity against malignant glioma and can potentiate the action of both chemotherapy and anti-angiogenics. The current study is designed to evaluate the anti-tumor activity of vorinostat when combined with BV among recurrent glioblastoma multiforme patients.

Conditions

• Recurrent Glioblastoma Multiforme
• Malignant Glioma
• Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	Vorinostat
DRUG	Bevacizumab

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-12-01
• Completion: 2016-02-01
• First posted: 2012-11-30
• Last updated: 2017-03-06
• Results posted: 2015-10-29

Locations

1 site across 1 country: United States