Clinical Trial Details
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NCT02234050 : Trabectedin for Recurrent Grade II/III Meningioma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Patient selection criteria

- Age 18 or older

- Histological diagnosis of 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

- 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 ULN, SGPT/ALT and SGOT/AST ? 2.5 x ULN

- Alkaline phosphatase ? 2.5 x ULN; if alkaline phosphatase > 2.5 ULN, ALP hepatic
isoenzyme and/or 5-nucleotidase and/or gamma glutyamyltransferase (GGT) must be
within the normal range

- Albumin ? 30 g/L

- Serum creatinine ? 1.5 x ULN

- Creatinine clearance > 30 ml/min as calculated by Cockcroft and Gault formula
(see Appendix E)

- Creatine phosphokinase (CPK) ? 2.5 x ULN

- Normal cardiac function (LVEF assessed by MUGA or ECHO within normal range of the
institution), normal 12 lead ECG (without clinically significant abnormalities). The
following unstable cardiac conditions are not allowed:

- Congestive heart failure

- Angina pectoris

- Myocardial infarction within 1 year before registration/randomization

- Uncontrolled arterial hypertension defined as blood pressure ? 150/100 mm Hg
despite optimal medical therapy

- Arrhythmias clinically significant

- Life expectancy of at least 9 weeks

- No history of any other invasive malignancy within the last 5 years (except
adequately treated non-melanoma skin cancer, clinicaly localized and very low risk
prostate cancer, and adequately treated cervical intraepithelial neoplasia)

- No serious illness or medical conditions, specifically: active infectious process;
chronic active liver disease, including chronic hepatitis B, C or cirrhosis

- No concomitant use of any other investigational agent or phenytoin

- Women of child bearing potential (WOCBP) must have a negative serum (or urine)
pregnancy test within 72 hours prior to the first dose of study treatment. Women of
childbearing / reproductive potential should use adequate birth control measures, as
defined by the investigator, during the study treatment period and for at least 3
months after the last study treatment. Men who are fertile must use effective
contraception during treatment with trabectedin and for 5 months thereafter. A highly
effective method of birth control is defined as one that results in low failure rate,
i.e. less than 1% per year, when used consistently and correctly.

- Female subjects who are breastfeeding should discontinue nursing prior to the first
dose of study treatment and until 3 months after the last study treatment.

- No known MRI or CT, including contrast media, contraindications

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the

- Patients with a buffer range from the normal values of +/- 5 % for hematology and +/-
10% for biochemistry are acceptable. A maximum of +/- 2 days for timelines may be

- Before patient randomization, written informed consent must be given according to
ICH/GCP, and national/local regulations.
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