RiNG
Research type
Research Study
Full title
Reirradiation (re-RT) and Niraparib (NIRA) in patients with recurrent Glioblastoma (rGBM)
IRAS ID
1005368
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2022-001706-22
Research summary
Glioblastoma (GBM) is the most common and serious type of primary brain cancer. There are different treatments for GBM including surgery, radiotherapy and chemotherapy. These options can control or reduce the size of the tumour. This is a trial for patients with GBM that was previously treated but has returned (called recurrent GBM, or rGBM). There is currently no standard treatment for rGBM.
We are testing a drug, niraparib, known as a PARP inhibitor. PARPs are proteins that help damaged cells repair themselves. Niraparib blocks PARP proteins from working and by doing so, cancer cells become too damaged to survive and so die. This trial aims to find the best dose of niraparib to give when treating rGBM, when given together with reirradiation (radiotherapy which uses high-energy rays to kill cancer cells).
The trial will run in UK hospitals. In the first 2 weeks of the trial, patients receive 10 doses of reirradiation. At the same time, niraparib capsules are taken orally at home, every day, until the patient is required to stop either because the treatment stops working or because of side-effects. Once the patient has finished niraparib treatment, they enter follow-up where they are seen once a year to see if they have had any late side-effects from trial treatment, how their disease is doing, and if further treatments have been received for it. This follow-up continues until the end of the trial.
The doses of niraparib to be tested are 100mg, 200mg and 300mg. Based on safety data reviewed at each dose, we will decide whether the next group of patients should receive an increased, decreased or the same dose of niraparib. Each patient will only receive niraparib at one dose level, unless they were to experience side-effects which meant that the dose needed to be reduced.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0086
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion