NCT00979017

Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme

Avastin in Combination With Temozolomide and Irinotecan for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Katy Peters · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients. This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.

Conditions

• Glioblastoma Multiforme
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	Avastin	Avastin, by intravenous infusion, 10 mg/kg every 14 days
DRUG	Temozolomide	Oral temozolomide at 200 mg/m2 daily for 5 days
DRUG	Irinotecan	Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-02-01
• Completion: 2013-01-01
• First posted: 2009-09-17
• Last updated: 2014-03-19
• Results posted: 2013-08-12

Locations

1 site across 1 country: United States