Overview

REO13 Melanoma With of Without GM-CSF

Status:
Withdrawn
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
Open-label, non-randomised, single centre study which will assess the presence of reovirus (Reolysin®), following intravenous administration with or without Granulocyte-macrophage colony-stimulating factor (GM-CSF) given to patients prior to surgery for metastatic melanoma. All patients will receive an initial low 'immunisation' dose of intravenous reovirus. Patients will be enrolled sequentially in to each of the two cohorts receiving either reovirus alone, or reovirus plus GM-CSF. For this study we anticipate 8-16 evaluable patients, up to 8 for each group. The endpoints of this study will compare the 2 treatment groups for reovirus tumour infiltration and replication. Compare the neutralising antibody development and cell-mediated immune response and identify any adverse events and laboratory toxicities.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Leeds
Collaborator:
Yorkshire Cancer Research
Treatments:
Sargramostim