Brain Metastases From Solid Tumors Clinical Trial
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
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.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment