NCT01164189

Bevacizumab in Recurrent Grade II and III Glioma

Randomized Trial Assessing the Significance of Bevacizumab in Recurrent Grade II and Grade III Gliomas - The TAVAREC Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide is more effective when given with or without bevacizumab in treating patients with recurrent glioma. PURPOSE: This randomized clinical trial is studying how well temozolomide works with or without bevacizumab in treating patients with recurrent glioma.

Detailed description

OBJECTIVES: Primary * To document the activity of both combination temozolomide plus bevacizumab and temozolomide alone in patients with recurrent grade II or grade III glioma without 1p/19q co-deletion. Secondary * To characterize the safety of treatment in these patients. * To document the quality of life and cognitive functioning, as a measure of clinical benefit, of these patients. * To explore qualification or occurrence of prognostic and/or predictive biomarkers of activity or efficacy in these patients. (exploratory) * To document the discordances between RANO and Macdonald's criteria for the evaluation of response and progression. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to institution, initial histology (grade II vs grade III), WHO performance status (0-1 vs 2), and prior treatment (radiotherapy \[RT\] alone, temozolomide \[TMZ\] or procarbazine, lomustine and vincristine \[PCV\] alone vs TMZ/RT). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral temozolomide as in arm I and bevacizumab IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients complete neurocognitive questionnaires (i.e., the Hopkins Verbal Learning test, the Controlled Oral Word Association test, and the Trail Making tests A and B). Quality-of-life assessment questionnaires, including EORTC QLQ-C30 and EORTC-BN20, are completed by both patients and caregivers/relatives at baseline and then periodically. Frozen tumor biopsies or paraffin blocks and blood specimens are collected for bio-banking and translational research. After completion of study therapy, patients are followed up every 3 months.

Conditions

• Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Bevacizumab (vial of 400mg/16mL) at a dose of 10 mg/kg bodyweight i.v. in 90 min on day 1 and day 14 of 4 week cycles
DRUG	Temozolomide	Temozolomide (250, 100, 20 and 5 mg caps) will be administered orally on day 1-5, 150-200 mg/m², and will be repeated every 4 weeks. This will be repeated for up to 12 cycles.

Timeline

• Start date: 2011-02-01
• Primary completion: 2017-01-19
• Completion: 2017-09-24
• First posted: 2010-07-16
• Last updated: 2019-02-28

Locations

39 sites across 8 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Switzerland, United Kingdom