Phase I trial of IMA950 multi-peptide vaccine plus GM-CSF in glioblast

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I trial of IMA950 (a novel multi-peptide vaccine) plus GM-CSF in patients with newly diagnosed glioblastoma

• IRAS ID

  43687

• Contact name

  Roy Rampling

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2009-015971-28

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  We wish to find out if a new vaccine called IMA950 will be useful in treating patients with the most agressive type of brain cancer called glioblastoma. This trial will be the first time this vaccine has been given to patients The vaccine will be given to patients who are newly diagnosed with glioblastoma and who are about to receive their first treatment for their cancer. This will be the standard treatment of surgery to remove as much of the cancer as possible, followed by chemotherapy with temozolomide alon'side radiotherapy, followed by further chemotherapy with temozolomide. The vaccine will be given in addition to this planned standard treatment which will not be changed because of the trial. The vaccine is made up of 12 different peptides (peptides are the building blocks of proteins) found to be more common on glioblastoma cancer cells than elsewhere in the body. The vaccine aims to activate the body's immune system in order to mount an attack on the brain cancer cells. The vaccine will be injected along with an injection of a growth factor called GM-CSF which is almost identical to a protein normally made by the body. This helps to boost the body's immune response to the vaccine. GM-CSF is available on the market and routinely used in cancer patients and has been used inoseveral clinical trials of cancer vaccines. The study aims to find out about the potential side effects of the vaccine and how they can be managed and how the body's immune system responds to the vaccine. The vaccine is given at what we consider to be a therapeutic dose to all patients and so we are also looking to see if the cancer responds. We aim to treat approximately 45 patientsat four hospitals in the UK.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/24

• Date of REC Opinion

  24 May 2010

• REC opinion

  Favourable Opinion