Trabectedin for Recurrent Grade II/III Meningioma

February 27, 2019 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Landesnervenklinik Wagner Jauregg
      • Vienna, Austria
        • Medical University Vienna - General Hospital AKH
  • Belgium
      • Brussels, Belgium
        • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
      • Edegem, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • U.Z. Leuven - Campus Gasthuisberg
      • Yvoir, Belgium
        • CHU Dinant Godinne - UCL Namur
  • France
      • Bordeaux, France, 33075
        • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
      • Bron, France
        • CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer
      • Dijon, France
        • Centre Georges-Francois-Leclerc
      • Lille, France
        • CHRU de Lille
      • Lyon, France
        • Centre Léon Bérard
      • Montpellier, France
        • Institut régional du Cancer Montpellier
      • Nice, France
        • CHU de Nice - Hopital Pasteur
      • Paris, France
        • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
      • Rennes, France
        • Centre Eugène Marquis
      • Villejuif, France
        • Gustave Roussy
  • Germany
      • Bonn, Germany
        • Universitaetsklinikum Bonn
      • Essen, Germany
        • Universitaetsklinikum - Essen
      • Frankfurt, Germany
        • Klinikum der J.W. Goethe Universitaet
      • Freiburg, Germany, 79106
        • Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig
      • Muenchen, Germany, 81377
        • Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern
      • Muenster, Germany
        • Universitaetsklinikum Muenster, Zentralklinikum
      • Regensburg, Germany
        • Universitaetskliniken Regensburg
      • Tubingen, Germany
        • Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen
  • Italy
      • Milano, Italy
        • Ospedale San Raffaele
      • Milano, Italy
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Padova, Italy
        • Istituto Oncologico Veneto IRCCS - Ospedale Busonera
      • Roma, Italy
        • Istituto Regina Elena / Istituti Fisioterapici Ospitalieri
      • Torino, Italy
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze
  • Netherlands
      • Amsterdam, Netherlands
        • Spaarne Gasthuis - Vrije Universiteit Medisch Centrum
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Rotterdam, Netherlands
        • Erasmus MC Cancer Institute - location Daniel den Hoed
  • Norway
      • Oslo, Norway
        • Oslo University Hospital - Radiumhospitalet
  • Spain
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clinic Universitari de Barcelona
      • Barcelona, Spain
        • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
      • L'Hospitalet de Llobregat, Spain
        • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois - Lausanne
      • Zurich, Switzerland
        • UniversitaetsSpital Zurich
  • United Kingdom
      • Bristol, United Kingdom
        • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
      • Edinburgh, United Kingdom
        • NHS Lothian - Western General Hospital
      • London, United Kingdom
        • Guy's and St Thomas' NHS - St Thomas Hospital
      • Newcastle, United Kingdom
        • Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 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 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 ICH/GCP, and national/local regulations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trabectedin
Patient will be treated with trabectedin
Drug: 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.
Other Names:
  • Yondelis
Other: Local standard of care
Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.
Other: Local standard of care
Left to the discretion of the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first
From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival at 6 months (PFS-6), median PFS (mPFS)
Time Frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first
From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first
Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration.
Time Frame: From the date of randomization until disease progression
From the date of randomization until disease progression
Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)
Time Frame: From the date of randomization up to the date of death, up to 12 months
From the date of randomization up to the date of death, up to 12 months
Safety (CTCAE v.4.0)
Time Frame: From randomization up to 30 days after administration of the last dose of protocol treatment or until the start of a new antitumor therapy, whichever occurs first.
From randomization up to 30 days after administration of the last dose of protocol treatment or until the start of a new antitumor therapy, whichever occurs first.
Health-related Quality of life (HRQol)
Time Frame: Untill six months after randomization
Untill six months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Matthias Preusser, Medical University Vienna - General Hospital AKH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

January 16, 2019

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1320-BTG
  • 2014-002446-47 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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