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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07292674

Enrollment

Registered

2013-01-29

Start date

2013-02-04

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced cancer Cancer Malignant neoplasm, unspecified

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 sal

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026