Trabectedin for Recurrent Grade II/III Meningioma

NCT ID: NCT02234050

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-01-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trabectedin

Patient will be treated with trabectedin

Group Type: EXPERIMENTAL

Trabectedin

Intervention Type: DRUG

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.

Local standard of care

Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.

Group Type: OTHER

Local standard of care

Intervention Type: OTHER

Left to the discretion of the investigator

Interventions

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.

Intervention Type: DRUG

Local standard of care

Left to the discretion of the investigator

Intervention Type: OTHER

Other Intervention Names

Yondelis

Eligibility Criteria

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
• 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 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 Multigated radionuclide angiography (MUGA) or Echocardiogram (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, clinically 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 trial
• 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 acceptable
• Before patient randomization, written informed consent must be given according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/ Good Clinical Practice (GCP), and national/local regulations.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Preusser

Role: STUDY_CHAIR

Medical University Vienna - General Hospital AKH

Locations

Landesnervenklinik Wagner Jauregg

Linz, , Austria

Medical University Vienna - General Hospital AKH

Vienna, , Austria

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

U.Z. Leuven - Campus Gasthuisberg

Leuven, , Belgium

CHU Dinant Godinne - UCL Namur

Yvoir, , Belgium

CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

Bordeaux, , France

CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

Bron, , France

Centre Georges-Francois-Leclerc

Dijon, , France

CHRU de Lille

Lille, , France

Centre Leon Berard

Lyon, , France

Institut régional du Cancer Montpellier

Montpellier, , France

CHU de Nice - Hopital Pasteur

Nice, , France

Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

Paris, , France

Centre Eugene Marquis

Rennes, , France

Gustave Roussy

Villejuif, , France

Universitaetsklinikum Bonn

Bonn, , Germany

Universitaetsklinikum - Essen

Essen, , Germany

Klinikum Der J.W. Goethe Universitaet

Frankfurt, , Germany

Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie

Freiburg im Breisgau, , Germany

Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

Heidelberg, , Germany

Universitaetsklinikum Leipzig

Leipzig, , Germany

Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

München, , Germany

Universitaetsklinikum Muenster, Zentralklinikum

Münster, , Germany

Universitaetskliniken Regensburg

Regensburg, , Germany

Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen

Tübingen, , Germany

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

Istituto Oncologico Veneto IRCCS - Ospedale Busonera

Padua, , Italy

Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

Roma, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

Torino, , Italy

Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

Erasmus MC Cancer Institute - location Daniel den Hoed

Rotterdam, , Netherlands

Oslo University Hospital - Radiumhospitalet

Oslo, , Norway

Hospital Clinic Universitari de Barcelona

Barcelona, , Spain

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

Barcelona, , Spain

Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

L'Hospitalet de Llobregat, , Spain

Hospital Universitario 12 De Octubre

Madrid, , Spain

Centre Hospitalier Universitaire Vaudois - Lausanne

Lausanne, , Switzerland

UniversitaetsSpital Zurich

Zurich, , Switzerland

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

Bristol, , United Kingdom

NHS Lothian - Western General Hospital

Edinburgh, , United Kingdom

Guy's and St Thomas' NHS - St Thomas Hospital

London, , United Kingdom

Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

Newcastle, , United Kingdom

Countries

Austria; Belgium; France; Germany; Italy; Netherlands; Norway; Spain; Switzerland; United Kingdom

References

Hundsberger T, Surbeck W, Hader C, Putora PM, Conen K, Roelcke U. [Meningioma: management of the most common brain tumour]. Praxis (Bern 1994). 2016 Apr 13;105(8):445-51. doi: 10.1024/1661-8157/a002320. German.

Reference Type: DERIVED

PMID: 27078728 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-002446-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-1320-BTG

Identifier Type: -

Identifier Source: org_study_id