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Brief Title: Radioimmunotherapy With 131I-L19SIP in Patients With Cancer
Official Title: A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER
Study ID: NCT01242943
Brief Summary: The aim of this Study Protocol is to provide a basis for the clinical development of 131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase I study.
Detailed Description: The L19SIP antibody is a fully human antibody, capable of preferential localization around tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the L19SIP antibody in SIP format, labelled with the radionuclide 131I, for the treatment of patients with different cancer types. The study follows a Phase I study performed with 131I-L19SIP in over 30 patients with cancer, which has shown an excellent tolerability at radioactive doses as high as 150 mCi and therapeutic benefit for some patients enrolled in the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital Pisa, Pisa, Tuscany, Italy
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc), Meldola, , Italy
Irccs Ospedale Casa Sollievo Della Sofferenza - San Giovanni Rotondo, San Giovanni Rotondo (FG), , Italy
University College London, UCL Cancer Institute, London, , United Kingdom
Name: Giuliano Mariani, Prof
Affiliation: University Hospital Pisa, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Tim Meyer, Dr
Affiliation: University College London (UCL) Cancer Institute
Role: PRINCIPAL_INVESTIGATOR