A Phase III Study of the Effects of Multikine on Cancer of the Oral Ca
Research type
Research Study
Full title
A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only.
IRAS ID
139505
Contact name
Jean-Pierre Jeannon
Contact email
Sponsor organisation
CEL-SCI Corporation
Eudract number
2010-019952-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 1 days
Research summary
The primary purpose of this clinical trial is to determine whether Leukocyte Interleukin Injection (LI) in combination with Cyclophosphamide, Indomethacin and nutritional supplementation with multivitamins plus zinc (CIZ) given before standard treatment will increase the overall survival of patients with advanced cancer of the oral cavity (mouth) beyond that currently achieved with standard treatment alone.
Current standard treatments for oral cavity cancer include surgery, radiotherapy and chemotherapy and these treatments are effective in treating early disease but for patients with advanced disease they are not so effective (data shows the median 3 year survival is 52% and the 5 year overall survival is 39%). Encouraging results have been obtained in patients who have received radiotherapy and chemotherapy at the same time (chemoradiotherapy) following surgery but further improvements are still needed.
The drug being tested is called Multikine and is a defined mixture of naturally derived and naturally occurring human cytokines (proteins released by a specific type of cell as part of the body's immune response). It is being tested together with a CIZ regime (Cyclophosphamide, Indomethacin and nutritional
supplementation with multivitamins plus zinc) to measure the ability of this treatment to stimulate the patients immune system prior to receiving standard of care treatments.Male and female adult patients with advanced oral cavity cancer, who can consent themselves, are eligible for inclusion in this study. This is a multi-national study with approximately 80 hospital sites globally, and plans to include up to 880 patients.
The study will last approximately 5 years, it is expected that it will take 2 years to recruit all the patients and they will receive study treatment for 3 weeks before receiving standard of care therapies. Patients will then be followed for 30-36 months.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1202
Date of REC Opinion
23 Jan 2015
REC opinion
Further Information Favourable Opinion