Bevacizumab in Recurrent Grade II and III Glioma
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.
Timeline
- Start
- 2011-02
- Primary completion
- 2017-01-19
- Completion
- 2017-09-24
Outcome
Missed primary endpoint
paper We found no evidence of improved overall survival with bevacizumab and temozolomide combination treatment versus temozolomide monotherapy. PMID 30115593 ↗
Publications
- Draaisma K, Tesileanu CMS, de Heer I, Klein M, Smits M, Reijneveld JC, Clement PM, de Vos FYF, Wick A, Mulholland PJ, Taphoorn MJB, Weller M, Chinot OL, Kros JM, Verschuere T, Coens C, Golfinopoulos V, Gorlia T, Idbaih A, Robe PA, van den Bent MJ, French PJ. Prognostic Significance of DNA Methylation Profiles at MRI Enhancing Tumor Recurrence: a Report from the EORTC 26091 TAVAREC Trial. Clin Cancer Res. 2022 Jun 1;28(11):2440-2448. doi: 10.1158/1078-0432.CCR-21-3725.
- van den Bent MJ, Klein M, Smits M, Reijneveld JC, French PJ, Clement P, de Vos FYF, Wick A, Mulholland PJ, Taphoorn MJB, Lewis J, Weller M, Chinot OL, Kros JM, de Heer I, Verschuere T, Coens C, Golfinopoulos V, Gorlia T, Idbaih A. Bevacizumab and temozolomide in patients with first recurrence of WHO grade II and III glioma, without 1p/19q co-deletion (TAVAREC): a randomised controlled phase 2 EORTC trial. Lancet Oncol. 2018 Sep;19(9):1170-1179. doi: 10.1016/S1470-2045(18)30362-0. Epub 2018 Aug 13.
- Ediebah DE, Reijneveld JC, Taphoorn MJ, Coens C, Zikos E, Aaronson NK, Heimans JJ, Bottomley A, Klein M; EORTC Quality of Life Department and Patient Reported Outcome and Behavioral Evidence (PROBE). Impact of neurocognitive deficits on patient-proxy agreement regarding health-related quality of life in low-grade glioma patients. Qual Life Res. 2017 Apr;26(4):869-880. doi: 10.1007/s11136-016-1426-z. Epub 2016 Oct 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |