Trabectedin for Recurrent Grade II/III Meningioma

Inclusion Criteria

• •Patient selection criteria
• •Age 18 or older
• •Histological diagnosis of World Health Organization (WHO) grade II (chordoid meningioma, clear cell meningioma, atypical meningioma) or WHO grade III (papillary meningioma, rhabdoid meningioma, anaplastic/malignant meningioma) according to WHO 2007 classification.
• •Radiologically documented progression of any existing tumor (growth \> 25% in the last year) or appearance of new lesions (including intra- and extracranial manifestations)
• •No more option for local therapy (resection or radiotherapy) after maximal feasible surgery and radiotherapy
• •No prior systemic anti-neoplastic therapy for meningioma
• •Measurable disease (10 x10 mm) on cranial MRI no more than 2 weeks prior to randomization.
• •WHO performance status 0-2
• •Adequate liver, renal and hematological function within 4 weeks prior to randomization, defined as:
• •* Neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL or hemoglobin ≥ 5.6 mmol/L, platelets ≥ 100 x 109/L
• +22 more criteria