Vaccination with Adjuvants, Peptides, Elimination of Regulatory Cells.

• Research type

  Research Study

• Full title

  In vivo 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 (VAPER: Phase 1 Pilot study)

• IRAS ID

  117895

• Contact name

  James Spicer

• Contact email

  james.spicer@kcl.ac.uk

• Sponsor organisation

  King's College London University

• Eudract number

  2014-003025-18

• ISRCTN Number

  ISRCTN07292674

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  The VAPER Trial will evaluate the safety, tolerability and patient acceptability of a programme of vaccination in patients with advanced malignancy. The patients will have undergone all known conventional therapies.

  In Part 1 we will recruit 10 patients, and 20 patients in Part 2. We hope to do this study over a 3 year period.
  Patients aged 16 years and over, with proven cancer of any type, will be invited to participate provided they fulfil the inclusion criteria. Each patient will undergo 8 (3 weekly) cycles of vaccination into the skin of the abdomen.

  The vaccine is a mixture of 7 peptides (small molecules) and Montanide, an adjuvant (increases response to the vaccine). The patients will also apply an ointment(imiquimod)) to the skin at the vaccination site to further increase the immune response.

  Prior to each vaccination all patients will receive low dose oral cyclophosphamide, a chemotherapeutic drug, to reduce and inhibit immunosuppressive cells found in large numbers in cancer patients and which suppress the immune response.

  Some patients will also be prescribed an oral medication, celecoxib, to further inhibit suppressor cell activity.

  Patients will be treated in an accredited Clinical Research Trial Facility in Research Oncology, Guy's Hospital, London, and St Luke's Cancer Centre, Guildford, carefully monitored to identify any side effects, document safety and tolerability, and investigated to assess the generation of an effective anticancer clinical and immune response.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  15/LO/0117

• Date of REC Opinion

  8 May 2015

• REC opinion

  Further Information Favourable Opinion