Recurrent High Grade Meningioma Clinical Trial
Official title:
Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group
| Verified date | February 2019 |
| Source | European Organisation for Research and Treatment of Cancer - EORTC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | January 16, 2019 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Landesnervenklinik Wagner Jauregg | Linz | |
| Austria | Medical University Vienna - General Hospital AKH | Vienna | |
| Belgium | Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme | Brussels | |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | U.Z. Leuven - Campus Gasthuisberg | Leuven | |
| Belgium | CHU Dinant Godinne - UCL Namur | Yvoir | |
| France | 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 | |
| Germany | Universitaetsklinikum Bonn | Bonn | |
| Germany | Universitaetsklinikum - Essen | Essen | |
| Germany | Klinikum Der J.W. Goethe Universitaet | Frankfurt | |
| Germany | Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie | Freiburg | |
| Germany | Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital | Heidelberg | |
| Germany | Universitaetsklinikum Leipzig | Leipzig | |
| Germany | Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern | Muenchen | |
| Germany | Universitaetsklinikum Muenster, Zentralklinikum | Muenster | |
| Germany | Universitaetskliniken Regensburg | Regensburg | |
| Germany | Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen | Tubingen | |
| Italy | Fondazione IRCCS Istituto Neurologico Carlo Besta | Milano | |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Istituto Oncologico Veneto IRCCS - Ospedale Busonera | Padova | |
| 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 | |
| Netherlands | Spaarne Gasthuis - Vrije Universiteit Medisch Centrum | Amsterdam | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Netherlands | Erasmus MC Cancer Institute - location Daniel den Hoed | Rotterdam | |
| Norway | Oslo University Hospital - Radiumhospitalet | Oslo | |
| Spain | 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 | |
| Switzerland | Centre Hospitalier Universitaire Vaudois - Lausanne | Lausanne | |
| Switzerland | UniversitaetsSpital Zurich | Zurich | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC |
Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first | ||
| Secondary | Progression Free Survival at 6 months (PFS-6), median PFS (mPFS) | From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first | ||
| Secondary | Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration. | From the date of randomization until disease progression | ||
| Secondary | Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS) | From the date of randomization up to the date of death, up to 12 months | ||
| Secondary | Safety (CTCAE v.4.0) | 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. | ||
| Secondary | Health-related Quality of life (HRQol) | Untill six months after randomization |