Temozolomide With or Without Bevacizumab in Treating Patients With Recurrent Glioma
Recruitment status was Recruiting
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.
Brain and Central Nervous System Tumors
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial Assessing the Significance of Bevacizumab in Recurrent Grade II and Grade III Gliomas - The TAVAREC Trial|
- Probability of survival at 1 year [ Designated as safety issue: No ]
- Objective response rate and duration of response [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival and survival at 24 months [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Clinical/neurological deterioration-free survival [ Designated as safety issue: No ]
- Steroid use [ Designated as safety issue: No ]
- Quality of life of patients and caregivers/relatives [ Designated as safety issue: No ]
- Cognitive deterioration [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Paris, France, 75651|
|Contact: Contact Person 33-142-16-0385 firstname.lastname@example.org|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center||Recruiting|
|Rotterdam, Netherlands, 3008 AE|
|Contact: Contact Person 31-10-704-1415 email@example.com|
|Investigator:||Martin J. van Den Bent, MD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Investigator:||Ahmed Idbaih||CHU Pitie-Salpetriere|