LuDo

• Research type

  Research Study

• Full title

  A Phase IIa trial of 177 Lutetium Dotatate in Children with Primary Refractory or Relapsed High-Risk Neuroblastoma

• IRAS ID

  77317

• Contact name

  Mark Gaze

• Eudract number

  2012-000510-10

• ISRCTN Number

  n/a

• Research summary

  High-risk neuroblastoma is the commonest extracranial solid tumour in children and accounts for 6-10% of all childhood cancers. Overall cure rates are low, and so effective new treatments are needed. 177Lutetium DOTATATE is an established molecular radiotherapy treatment used in adults and shows good response rates with tolerable or manageable side effects. This study aims to assess how children respond to the treatment, and the results of this trial may lead to further studies in the future. The primary aims of this study is to evaluate the safety and side effects experienced from 177Lutetium DOTATATE molecular radiotherapy treatment, and assess how effective it is in treating children with neuroblastoma where the disease has reoccurred (relapsed) or is not responding to other forms of treatment (refractory). Patients aged between 18 months and 18 years of age will be eligible to participate in the study if they have confirmed diagnosis of relapsed or primary refractory high-risk neuroblastoma. Patients must have a life expectancy of greater than 3 months and together with their parents, must give relevant written informed consent to participate in the study, as well as agreeing to be followed up for a period of up to 5 years. The study will be recruiting from the University College Hospital, London. Patients will receive a maximum of 4 molecular radiotherapy doses which will be given 8-12 weeks apart to allow time for the patients blood count to recover. Therefore the treatment period could range from 32-48 weeks. Prior to and following treatment, patients will be required to undergo imaging such as nuclear medicine scans, CT scans or MRI scans as well as various other investigations such as blood tests and physical examinations. The trial will be ongoing for 2 years and aims to enrol up to 24 children.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/1422

• Date of REC Opinion

  9 Oct 2012

• REC opinion

  Favourable Opinion