XRT +/- vandetanib in CNS melanoma

• Research type

  Research Study

• Full title

  A randomised double blind phase 2 trial of whole brain radiotherapy with or without vandetanib in metastatic melanoma with brain metastases

• IRAS ID

  82648

• Sponsor organisation

  Oxford University Hospitals NHS Foundation Trust

• Eudract number

  2011-000661-12

• ISRCTN Number

  n/a

• Research summary

  This is a multi-centre randomised double blind placebo controlled phase 2 study of the treatment of patients with advanced melanoma which has spread (metastasised) to the brain. The study will compare the effectiveness of standard whole brain radiotherapy treatment (WBRT) alone with WBRT plus a novel anti-cancer drug called vandetanib in controlling melanoma brain metastases.Current treatment for patients with melanoma brain metastases has limited effectiveness and their management represents a significant unmet medical need.Vandetanib is a type of drug known as a tyrosine kinase inhibitor. It has shown both anti-tumour activity and the ability to increase the effect that radiotherapy has against cancer cells. Thus vandetanib plus radiotherapy may be more effective than radiotherapy alone in controlling cancer in this patient group.Patients with metastatic melanoma who have been diagnosed with brain metastases but not yet received any whole brain radiotherapy treatment will be eligible to be considered for this study.All patients enrolled into the study who meet the eligibility criteria will be treated with whole brain radiotherapy treatment (the current standard of care for this disease). Half of the patients in the study will also receive daily vandetanib tablets for the duration of their radiotherapy treatment. The other half will receive placebo tablets over the same period.This study will be sponsored and run by the Oncology Clinical Trials Office (OCTO), Department of Oncology, University of Oxford. The plan is to recruit 80 patients in total (40 to each treatment group), following recruitment of 6 patients for the safety cohort.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0282

• Date of REC Opinion

  5 Aug 2011

• REC opinion

  Favourable Opinion