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Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment
Sponsor: University Hospital Muenster
Summary
Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy . Following study objectives will be analyzed: * Determining the Maximum Tolerated Dose (MTD) * Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher * Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2h,24h,48h, 72h p.i. and on day 5-7) * Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2h,24h,48h, 72h p.i. and on day 5-7) * Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion
Official title: A Phase I Trial to Determine the Maximum Tolerated Dose and Patient-specific Dosimetry of Fractionated Intracavitary Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-01-22
Completion Date
2026-04
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Lu-177 labeled 6A10-Fab-fragments
The antibody 6A10 is a specific CA12 Inhibitor, a highly specific glioma cell-associated enzyme; all tumor cells are CA12-positive, while its expression in normal brain is very low, and Lu-177 has a comparable β-emission, but a significantly low γ-Emission.
Locations (7)
Klinik für Allgemeine Neurochirurgie des Universitätsklinikums Köln
Cologne, Germany
Klinik für Nuklearmedizin des Universitätsklinikums Köln
Cologne, Germany
Klinik für Neurochirurgie des Universitätsklinikums Essen
Essen, Germany
Klinik für Nuklearmedizin, Strahlenklinik des Universitätsklinikums Essen
Essen, Germany
Klinik für Nuklearmedizin der Universität Münster
Münster, Germany
Universitätsklinikum Würzburg - Neurochirurgie
Würzburg, Germany
Universitätsklinikum Würzburg - Nuklearmedizin
Würzburg, Germany