Glioma Clinical Trial
Official title:
A Phase 2a, Multi-Center, Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma
The purpose of this study is to determine the recommended dosing of I-131-CLR1404, a
radiolabeled therapy compound, for treating subjects with glioma.
Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the
study will be conducted in three phases, dosimetric, therapy, and follow-up. In the
dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole
body imaging on on the day of infusion and on post-infusion days 2, 3, and 7 for assessment
of biodistribution and tumor uptake of I-131-CLR1404. If normal and expected biodistribution
are demonstrated, the subject will begin the therapy phase. In the therapy phase, the
subjects will receive a dose based on body surface area and may receive additional doses if
they meet dosing criteria. After the last treatment dose, subjects will enter the follow-up
phase and will be followed monthly.
All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to
injection of the dosimetric dose, and continuing for 14 days after the administration of the
therapy dose.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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