Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: reoglio phase I trial results
dc.contributor.author | Kendall, J. | |
dc.contributor.author | Chalmers, A. | |
dc.contributor.author | McBain, Catherine A | |
dc.contributor.author | Melcher, A. | |
dc.contributor.author | Samson, A. | |
dc.contributor.author | Phillip, R. | |
dc.contributor.author | Brown, S. | |
dc.contributor.author | Short, S. | |
dc.date.accessioned | 2021-01-06T11:15:18Z | |
dc.date.available | 2021-01-06T11:15:18Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | Kendall J, Chalmers A, McBain C, Melcher A, Samson A, Phillip R, et al. Ctim-14. Pelareorep and Granulocyte-Macrophage Colony-Stimulating Factor (Gm-Csf) with Standard Chemoradiotherapy/Adjuvant Temozolomide for Glioblastoma Multiforme (Gbm) Patients: Reoglio Phase I Trial Results. Neuro-Oncology. 2020;22(Supplement_2):ii35-ii6. | en |
dc.identifier.doi | 10.1093/neuonc/noaa215.148 | en |
dc.identifier.uri | http://hdl.handle.net/10541/623593 | |
dc.description.abstract | BACKGROUND: Oncolytic viruses represent a novel treatment approach in GBM through oncolytic targeting as well as local immune activation. We designed a phase Ib, open-label study of intravenous reovirus (pelareorep) with GM-CSF alongside standard chemoradiotherapy to assess safety and tolerability. METHODS: 15 patients with newly diagnosed GBM were treated with GM-CSF 50mg subcutaneously (days 1–3) and pelareorep (days 4–5) in weeks 1 and 4 of chemoradiotherapy, and week 1 of adjuvant temozolomide course: 7 patients received 1x1010TCID50 (dose level 1); 8 received 3x1010TCID50 (dose level 2). The primary objective was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain preliminary assessment of the activity of the combination and assess treatment compliance. RESULTS: 1 dose limiting toxicity (DLT) and 20 SAEs were experienced overall; median number of SAEs per patient was 2. Commonest SAEs were nervous system disorders, predominantly seizures. SARs included fever/ flu-like episodes (n=5), fall (n=1) and headache (n=1). Two SUSARs occurred in dose level 2, classed as vascular disorders manifesting as hypotension episodes – one was a DLT. Suspected relationship of SARs: pelareorep (n=6); temozolomide (n=1); radiotherapy (n=1); all study drugs (n=1). 87% of patients (n=13) completed chemoradiotherapy without unplanned delays. Adjuvant treatment was delayed in 21% of cycles overall, with the majority due to inadequate haematology/biochemistry values (44% of delays). Pelareorep was omitted in 4 instances in 4 patients during chemoradiotherapy and omitted in 4 instances in 3 patients during adjuvant treatment. CONCLUSION: We present the first clinical data using intravenous pelareorep with GM-CSF alongside standard chemoradiotherapy in patients with GBM, suggesting that the combination is tolerable. Further analysis is underway and efficacy results will be ready for presentation at the conference. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1093/neuonc/noaa215.148 | en |
dc.title | Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: reoglio phase I trial results | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | CTRU, University of Leeds, Leeds, United Kingdom, | en |
dc.identifier.journal | Neuro-Oncology | en |
dc.description.note | en] |