Brain tumour clinical trial title

ReoGlio (Study ID: 31893)

Brain tumour type

Glioblastoma, 

Website

www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-reolysin-and-gm-csf-for-glioblastoma-multiforme-reoglio#undefined

Description:

This study will assess the safety and tolerability of the reovirus (REOLYSIN®) and granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with standard of care chemoradiotherapy and adjuvant chemotherapy in adult patients with glioblastoma multiforme (GBM). Currently, patients with GBM receive debulking surgery followed by 6 weeks of chemoradiotherapy with concurrent chemotherapy for 6 months. This study will look at combining this current treatment with Reolysin and GM-CSF as previous studies have demonstrated tolerability of the virus with chemotherapy with early evidence of anti-tumour activity. Preclinical data also supports the addition of GM-CSF as it has been demonstrated it increases the number of white blood cells which are used to protect and transport the virus to the tumour therefore ensuring the virus reaches the cancer cells. There are two parts to this study; a dose escalation phase and a non-randomised expansion phase. In the dose escalation phase, six patients will be treated per cohort in order for any toxicities to be observed. Once the first six patients have been treated and their data reviewed, it will be decided whether to increase or decrease the dose for the next six patients depending on the toxicity observed. Once the safest dose is found this will be used to treat an additional 12 patients in the expansion phase. All patients, whether in the escalation phase or expansion phase, will receive six weeks of chemoradiotherapy followed by six months of adjuvant chemotherapy as they would if they were not participating in this study. They will then receive GM-CSF and Reolysin during weeks 1 and 4 of chemoradiotherapy and for one week each month during adjuvant chemotherapy. The study will take place in five hospitals and recruit up to 24 patients. Research Summary

Date added: 11th January 2019

Open/Closed: Open

Trial ends: May 2020

Provider

University of Leeds

Contact details

Miss Amber Reid :


Leeds
LS2 9JT
E-mail: ctru-reoglio@leeds.ac.uk
Telephone:

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