Vaccination with Adjuvants, Peptides and Elimination of Regulatory Cells: Enhancement of the body's anticancer immunity by vaccination

ISRCTN	ISRCTN07292674
DOI	https://doi.org/10.1186/ISRCTN07292674
EudraCT/CTIS number	2014-003025-18
Secondary identifying numbers	01; 117895

Submission date: 17/12/2012
Registration date: 29/01/2013
Last edited: 29/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-using-a-vaccine-and-chemotherapy-to-treat-advanced-cancer-vaper

Contact information

Prof Oleg Eremin
Scientific

University Department of GI Diseases
Floor E, West Block
Queen's Medical Centre Campus
Nottingham
NG7 2UH
United Kingdom

Email	oleg.eremin@nuh.nhs.uk

Study information

Study design	Single-centre open-label fixed-dose comparative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	In vitro generation of optimal tumour antigen-specific anticancer immune responses, by vaccination with Human Telomerase Reverse Transcriptase (HTERT) peptides, in combination with specific adjuvants and elimination of immunosuppressive regulatory cells, in patients with advanced cancer
Study acronym	VAPER
Study objectives	Vaccination with HTERT peptides in combination with specific adjuvants and elimination of regulatory suppressor cells can enhance anticancer immune responses.
Ethics approval(s)	London - London Bridge Research Ethics Committee, 08/05/2015, REC ref: 15/LO/0117
Health condition(s) or problem(s) studied	Advanced cancer
Intervention	Patients are randomly allocated to either Group A or Group B. All patients (groups A and B) will receive eight intradermal injections of 2 ml, consisting of 700ug of HTERT peptides in 1 ml normal saline (NS) mixed with Montanide ISA-51 VG,1 ml, given at 3 weekly intervals. Topical Imiquimod 12.5 mg will be applied by the patient to the vaccination site day 1-5 post vaccination. All patients (groups A and B) will receive a 10 day course of low dose oral Cyclophosphamide day 1-10 of each vaccination cycle. Group B patients will take Celecoxib 400mg bd PO daily for the duration of the trial.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Human Telomerase Reverse Transcriptase (HTERT) peptides, cyclophosphamide
Primary outcome measure	To establish that the study is safe, well tolerated and patient acceptable. Patients wil be asked to complete validated questionaires (Mood Rating Scale, Hospital Anxiety and Depression Scale, Patient Attitude to Treatment Scale, FACT-Biological Response Modifiers) prior to treatment, at each vaccination visit and 4 weeks after the final vaccination. The forms will be evaluated and statistically analysed by Chi square and Fisher's exact tests at the end of treatment. Morbidity, side effects of treatment, will be documented at each clinic visit. Serious adverse events (SAEs) and sudden unexpected serious adverse reactions (SSUSARs) will be documented if and when they occur.
Secondary outcome measures	The generation of specific anticancer immunological responses and objective evidence of clinical responses during the programme. Blood will be taken for assessment of immunological parameters prior to treatment, at each vaccination visit and 4 weeks after the end of treatment. Tumour markers, if present, will also be monitored at each visit and documented. Reduction or stasis of tumour volume will be recorded at each visit if there is measureable tumour.
Overall study start date	04/02/2013
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	85 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Age 18-85, either sex 2. Histologically or cytologically proven cancer 3. No further beneficial anticancer therapy available 4. Completed treatment at least 4 weeks previously 5. Post menopausal or sterilised or practising contraception 6. WHO status 3 or less 7. Life expectancy at least 30 weeks 8. Ability to give informed written consent
Key exclusion criteria	1. Pregnancy, lactation 2. Men and premenopausal women unwilling to practise reliable contraception 3. Inability to give informed written consent 4. Cerebral metastasis 5. Autoimmune disorders 6. Undergoing immunosuppressive therapy 7. Cardiovascular disease:coronary artery disease,major cardiac disease [left ventricular ejection fraction (LVEF <50%)], poorly controlled hypertension 8.Peptic ulceration,inflammatory bowel disease 9. Allergy to nonsteroidal anti-inflammatory drug (NSAID) therapy, celecoxib, asthma or allergy following aspirin 10. Allergy to sulphonamides 11. Past history of stroke or transient ischaemic attacks
Date of first enrolment	04/02/2013
Date of final enrolment	31/12/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Nottingham University Hospitals NHS Trust

Nottingham
NG7 2UH
United Kingdom

Sponsor information

Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre

c/o Dr Brian Thomson
Research & Innovation
Nottingham Integrated Clinical Research Centre
C Floor, South Block
Queen's Medical Centre Campus
Derby Road
Nottingham
NG7 2UH
England
United Kingdom

Phone	+44 (0)115 924 9924 ext 70675
Email	brian.thomson@nottingham.ac.uk
Website	https://www.nuh.nhs.uk

King's College Health Partners Clinical Trials Office
University/education

c/o Jackie Pullen
Academic Health Sciences Centre
F16 Tower Wing
Guy's Hospital, Great Maze Pond
London
SE1 9RT
England
United Kingdom

Phone	+44 (0)20 7188 5732
Email	jackie.pullen@kcl.ac.uk

Nottingham University Hospitals NHS Trust
Not defined

Website	http://www.nuh.nhs.uk/
"ROR"	https://ror.org/05y3qh794

Funders

Funder type

Charity

Candles Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

29/03/2018: Ethics approval information was added and the end date was changed from 04/02/2016 to 31/12/2018.
15/12/2015: Link to plain English summary added.