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REO13 Melanoma With of Without GM-CSF

NCT03282188 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-05-04

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Reolysin

Reolysin® is a proprietary isolate of Reovirus Type 3 Dearing, a non-enveloped human reovirus with a genome that consists of 10 segments of double-stranded RNA. The human reovirus possesses an innate ability to replicate specifically in transformed cells possessing an activated Ras signalling pathway, a situation often found in malignant cells. Reovirus has been shown to reach and target melanoma cancer cells.

DRUG

GM-CSF

GM-CSF is a recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. GM-CSF is a key cytokine in the differentiation of dendritic cells. It has been used as an immune adjuvant in therapeutic vaccines in pre-clinical and clinical studies, administered as cytokine released from gene-transduced tumour or stromal cells or as recombinant protein. At low doses GM-CSF may enhance migration and differentiation of dendritic cells to local antigen presentation, and is a potent adjuvant to generate specific systemic anti-tumour efficacy.

Sponsors & Collaborators

  • Yorkshire Cancer Research

    collaborator OTHER

  • University of Leeds

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-07-31
Completion
2018-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282188 on ClinicalTrials.gov