NCT02234050

Trabectedin for Recurrent Grade II/III Meningioma

Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

Detailed description

This is a randomized open label multicenter comparative phase II trial. The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.

Conditions

• Recurrent High Grade Meningioma

Interventions

Type	Name	Description
DRUG	Trabectedin	Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
OTHER	Local standard of care	Left to the discretion of the investigator

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-07-01
• Completion: 2019-01-16
• First posted: 2014-09-09
• Last updated: 2025-07-10
• Results posted: 2025-07-10

Locations

47 sites across 10 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Switzerland, United Kingdom