Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion 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 intraand
extracranial manifestations).
?Measurable disease (10 x10 mm) on cranial MRI or CT
thorax/abdomen no more than 2 weeks prior to randomization
?WHO performance status 0-2
?Adequate liver, renal and hematological function within 2 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 = ULN, SGPT/ALT and SGOT/AST = 2.5 x ULN
?Alkaline phosphatase = 2.5 x ULN; if alkaline phosphatase > 2.5 ULN,
hepatic isoenzymes 5-nucleotidase 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
Women of child bearing potential (WOCBP) must have a negative serum
(or urine) pregnancy test within 72 hours prior randomization (and
again within 72 hours prior to to the first dose of study treatment).
Patients of childbearing / reproductive potential should use adequate
birth control measures, as defined below, 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. Methods that can achieve a
failure rate of less than 1% per year when used consistently and
correctly are considered as highly effective birth control methods. Such
methods include:
? combined (estrogen and progestogen containing) hormonal
contraception associated with inhibition of ovulation:
? oral
? intravaginal
? transdermal
? progestogen-only hormonal contraception associated with inhibition
of ovulation:
? oral
? injectable
? implantable
? intrauterine device (IUD)
? intrauterine hormone-releasing system ( IUS)
? bilateral tubal occlusion
? vasectomised partner
? sexual abstinence
? Acceptable birth control methods that result in a failure rate of more
than 1% per year include:
? progestogen-only oral hormonal contraception, where inhibition of
ovulation is not the primary mode of action
? male or female condom with or without spermicide
? cap, diaphragm or sponge with spermicide
?Female subjects who are breast feeding should discontinue nursing
prior to the first dose of study treatment and until 3 months after the
last study treatment.
?Absence of any psychological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol

Exclusion Criteria

?More option for local therapy (resection or radiotherapy) after maximal
feasible surgery and radiotherapy.
?Prior systemic anti-neoplastic therapy for meningioma (patient may
have received prior radionuclide therapy).
?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).
?Serious illness or medical conditions, specifically: active infectious
process; chronic active liver disease, including chronic hepatitis B, C or
cirrhosis.
? Concomitant use of any other investigational agent, phenytoin, or
vaccination to yellow fever.
? Known hypersensitivity or contraindication to trabectedin or any of
the ingredients of the trabectedin solution for infusion
? Known MRI or CT, including contrast media, contraindications.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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