Vaccination with peptides (molecules) and other ingredients which stimulate the anticancer immune system in patients with advanced cancers

Phase 1

• Conditions: Advanced malignancies; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003025-18-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-17
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Age =16
Histologically or cytologically proven solid tumour
No further anticancer therapy suitable
Prior anticancer treatment completed =4 weeks previously- Endocrine therapy for prostate cancer may continue.
Post-menopausal, or sterilised or practising contraception
WHO status =2
Ability to give informed written consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Exclusion criteria for Arms A and B

Major affective disorder/psychosis
Pregnancy, lactation
Sexually active men and premenopausal women unwilling to practise a highly effective method of contraception
Autoimmune disorders
Undergoing immunosuppressive therapy
Central nervous system malignancies (primary and secondary)
Cardiovascular disease: Coronary artery disease, other major cardiac disease (including documented LVEF <50%), poorly controlled hypertension (diastolic >100mmHg)
Inability to discontinue treatment with oral anticoagulants or treatment-dose heparin.
Steroids or other immunosuppressive drugs (see Section 5.6.2)
Insufficient understanding of the Trial

Exclusion criteria for Arm B only

Peptic ulceration (endoscopically confirmed active disease, bleed within the last 12 months), inflammatory bowel disease
Allergy to NSAID therapy, celecoxib; asthma or allergy following aspirin or sulphonamides
Past history of a stroke or transient ischaemic attacks
Creatinine = 1.5 upper limit of normal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified