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.
Who can participate
Age range18 Years
SexALL
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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
* Total Bilirubin ≤ 1 x Upper Limit of Normal (ULN), serum glutamate pyruvate transaminase(SGPT)/ Alanine Aminotransferase (ALT) and serum glutamate oxaloacetate transaminase (SGOT)/ Aspartate Aminotransferase (AST) ≤ 2.5 x ULN
* Alkaline phosphatase ≤ 2.5 x ULN; if alkaline phosphatase \> 2.5 ULN, Alkaline Phosphatase (ALP) hepatic isoenzyme and/or 5-nucleotidase and/or gamma glutamyltransferase (GGT) must be within the normal range
* Albumin ≥ 30 g/L
* Serum creatinine ≤ 1.5 x ULN
* Creatinine cle…
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first up.PFS was assessed by its median the point time at which 50% of the patients have experienced disease progression or death.
Trial details
NCT IDNCT02234050
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC