131I-L19SIP RIT plus External Beam Radiation in brain metastases

• Research type

  Research Study

• Full title

  A prospective non-randomized study of 131I-L19SIP Radioimmunotherapy (RIT) in combination with Whole Brain Radiation Therapy (WBRT) in patients with multiple brain metastases from solid tumors

• IRAS ID

  41054

• Contact name

  Paul Mulholland

• Sponsor organisation

  Philogen S.p.A

• Eudract number

  2009-013002-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  131I-L19SIP, the investigational compound that is tested in this study, is a medicine that has been studied previously in clinical trials both in the UK (at UCLH London) and in Italy. 131I-L19SIP is a radio immunotherapy (RIT) drug that selectively delivers ionizing radiation to the tumor via an antibody moiety. The antibody (in this study the antibody is L19SIP) works as a vehicle carrying the radiation source (in this study the radiation source is Iodine-131) directly to the tumour cells. In this way, the tumour mass is irradiated in a focused and specific way. This study was designed in order to test the feasibility of the combination treatment with RIT and whole brain radiation (WBRT)in patients affected by multiple brain metastases, originated from malignant solid tumours, and to spot evidence of efficacy. The combination of RIT with WBRT could result in a synergistic effect on the tumour. Consequently, such a combined approach would result in a better control of the tumour and of the brain metastases, and possibly in a growth retardation of the metastases in other organs. The study will involve a maximum of 40 patients treated with 131I-L19SIP and will take place in several hospitals in Europe. The scope of this study is to investigate the ability of the 131I-L19SIP antibody to localize and accumulate at the brain metastases sites, and to evaluate the safety and efficacy of the administration of RIT with 131I-L19SIP combined with WBRT.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  10/H1107/13

• Date of REC Opinion

  28 May 2010

• REC opinion

  Further Information Favourable Opinion