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Brief Title: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiation in Patients With Multiple Brain Metastases From Solid Tumors
Official 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
Study ID: NCT01125085
Brief Summary: The aim of this Proof of Concept study is to determine the therapeutic potential of the L19SIP antibody, labeled with the radionuclide 131I in combination with external beam radiation, for the treatment of patients with multiple brain metastases following the promising results with this agent in previous clinical studies. 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 in most aggressive types of cancer. The presented study follows a Phase I and a subsequent Phase I/II dose finding and efficacy study with the same agent in patients with a variety of cancers where 131I-L19SIP had shown an excellent tolerability and therapeutic benefit for some patients enrolled in the study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Irccs Centro Di Riferimento Oncologico (Cro) - Aviano, Aviano, , Italy
Ospedali Riuniti Di Bergamo, Bergamo, , Italy
Azienda Ospedaliero UNIVERSITARIA CAREGGI DI FIRENZE, Firenze, , Italy
ASUR Zona Territoriale 9, Medicina Nucleare Ospedale di Macerata, Macerata, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli, Napoli, , Italy
Arcispedale Santa Maria Nuova Di Reggio Emilia, Reggio Emilia, , Italy
Irccs Istituto Clinico Humanitas, Rozzano (mi), , Italy
Irccs Ospedale Casa Sollievo Della Sofferenza - San Giovanni Rotondo, San Giovanni Rotondo (FG), , Italy
Barts and the London NHS Trust Hospital, London, , United Kingdom
UCLH, Department of Cancer Medicine, London, London, , United Kingdom
Name: Secondo Lastoria, Dr
Affiliation: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI
Role: PRINCIPAL_INVESTIGATOR
Name: Paul Mullholand, Dr
Affiliation: UCLH, Department of Cancer Medicine, London (UK)
Role: PRINCIPAL_INVESTIGATOR