Condition category
Cancer
Date applied
17/12/2012
Date assigned
29/01/2013
Last edited
15/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Oleg Eremin

ORCID ID

Contact details

University Department of GI Diseases
Floor E,West Block
Queen's Medical Centre Campus
Nottingham
NG7 2UH
United Kingdom
-
oleg.eremin@nuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01

Study information

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

Acronym

VAPER

Study hypothesis

Vaccination with HTERT peptides in combination with specific adjuvants and elimination of regulatory suppressor cells can enhance anticancer immune responses.

Ethics approval

NRES Committee East Midlands-Nottingham 1 - approval pending

Study design

Single centre open label fixed dose comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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.

Details of co-sponsor:
c/o Jackie Pullen
King's College Health Partners Clinical Trials Office
Academic Health Sciences Centre
F16 Tower Wing
Guy's Hospital, Great Maze Pond
London SE1 9RT
Tel: +44 (0)20 7188 5732
Email: jackie.pullen@kcl.ac.uk

Intervention type

Drug

Phase

Phase I/II

Drug names

Human Telomerase Reverse Transcriptase (HTERT) peptides, cyclophosphamide

Primary outcome measures

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 trial start date

04/02/2013

Overall trial end date

04/02/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

04/02/2013

Recruitment end date

04/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of GI Diseases
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

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
United Kingdom
+44 (0)115 924 9924 ext 70675
brian.thomson@nottingham.ac.uk

Sponsor type

Hospital/treatment centre

Website

https://www.nuh.nhs.uk

Funders

Funder type

Charity

Funder name

Candles Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/12/2015: Link to plain English summary added.