|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Vaccination with Adjuvants, Peptides and Elimination of Regulatory Cells: Enhancement of the body's anticancer immunity by vaccination |
| ISRCTN | ISRCTN07292674 |
| DOI | 10.1186/ISRCTN07292674 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Vaccination with Adjuvants, Peptides and Elimination of Regulatory Cells: Enhancement of the body's anticancer immunity by vaccination |
| 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 |
| Serial number at source | 01 |
| Study hypothesis | Vaccination with HTERT peptides in combination with specific adjuvants and elimination of regulatory suppressor cells can enhance anticancer immune responses. |
| Lay summary | Lay summary under review with external organisation |
| Ethics approval | NRES Committee East Midlands-Nottingham 1 - approval pending |
| Study design | Single centre open label fixed dose comparative study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Advanced cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 04/02/2013 |
| Anticipated end date | 04/02/2016 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 30 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | Candles Charity (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Oleg Eremin |
| Address |
University Department of GI Diseases
Floor E,West Block Queen's Medical Centre Campus |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| oleg.eremin@nuh.nhs.uk | |
| Sponsor | Nottingham University Hospitals NHS Trust (UK) |
| Address |
c/o Dr Brian Thomson
Research & Innovation Nottingham Integrated Clinical Research Centre C Floor, South Block Queen's Medical Centre Campus Derby Road |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| Tel | +44 (0)115 924 9924 ext 70675 |
| brian.thomson@nottingham.ac.uk | |
| Sponsor website: | https://www.nuh.nhs.uk |
| Date applied | 17/12/2012 |
| Last edited | 08/03/2013 |
| Date ISRCTN assigned | 29/01/2013 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
