Vaccinia Isolated PERfusion
Research type
Research Study
Full title
A Phase I Open-Label, Dose-Escalating Study of the Safety, Tolerability and Tumour Specific Replication of Green Fluorescent Protein-Encoding Genetically Engineered Attenuated Vaccinia Virus (GL-ONC1) Administered by Isolated Limb Perfusion with Melphalan and Tasonermin in Patients with Advanced Extremity Melanoma and Soft Tissue Sarcoma.
IRAS ID
123401
Contact name
Andrew Hayes
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2012-005654-38
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Isolated limb perfusion (ILP) is an effective way of treating advanced melanoma and sarcoma of the limbs that would otherwise necessitate an amputation. It has been shown that limb amputation does not improve survival and, therefore, the focus of treatment is justifiably on limb preservation.
ILP treats cancer by perfusing only the diseased limb with anti-cancer drugs at higher, more effective doses than would be possible by standard intravenous injection. ILP involves connecting the blood vessels of the diseased limb to a heart and lung bypass machine separating the limb from the rest of the patient’s circulation. However, the highly localized way in which ILP is given means that it cannot change the risk that disease will spread elsewhere in the body in the form of metastases. Therefore, there is an urgent need to develop ways in which ILP can treat the affected limb (loco-regional disease) and the rest of the body (systemic disease).
A promising new type of treatment is oncolytic vaccinia virus. Oncolytic vaccinia has the ability to target cancer cells directly whilst leaving normal cells relatively unscathed. Once inside the tumour cells, they replicate and then burst out of the cancer cell, killing it. Importantly, oncolytic viral infection of tumours can alert the patient’s own immune system to the presence of disease and trigger the destruction of tumour cells throughout the body.
This is a phase I study looking at safety and maximum dose tolerated in patients in whom ILP is recommended. This study will be conducted at The Royal Marsden Hospital, which acts as a national referral centre for ILP.
In this study the product used, vaccinia virus GL-ONC1 has been attenuated, weakening it to reduce its virulence but still enabling it to infect and kill cancer cells.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0537
Date of REC Opinion
20 Nov 2013
REC opinion
Further Information Favourable Opinion