EORTC 1320
Research type
Research Study
Full title
Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.
IRAS ID
181026
Contact name
Joanne Lewis
Contact email
Sponsor organisation
European Organization for Research and Treatment of Cancer (EORTC)
Eudract number
2014-002446-47
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Meningiomas are one of the commonest primary brain tumour group - the majority are benign. The atypical meningiomas (grade II) and the malignant meningiomas (grade III) are normally treated with surgery and radiotherapy. Once these modalities have been exhausted there are systemic treatment options but outcomes are disappointing and survival poor.The quality of medical literature literature is lacking and novel therapies are urgently needed. This study aims to collect data on the activity of trabectedin in the more aggressive meningioma patients that have no more surgical or radiotherapy treatment options. The study will also look at safety of the drug and quality of life of patients in the study with recurrent high grade meningioma.
Trabectedin is made from a molecule isolated from the sea squirt.The patients will be consented to a random allocation of standard systemic therapy care for their institution versus trabectedin therapy with a 2 to 1 chance of receiving the experimental drug.
The experimental drug - trabectedin is given via a drip every 3 weeks and there is the need to give a dose of dexamethasone (steroid) pre- treatment.
There are known drug interactions with trabectedin and these are fully described in the protocol and eligibility criteria.
For those on the standard treatment arm the investigating hospital is asked to state a standard approach currently used for patients as described above.
Patients are treated until one of the withdrawal criteria are met and patients are assessed every 2 months by MRI scan.
Trabectedin has been used in other tumour types in thousands of patients and toxicities are well understood and tend to be mild - however anti-emetics are needed.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0274
Date of REC Opinion
24 Sep 2015
REC opinion
Further Information Favourable Opinion