Spots Global Cancer Trial Database for Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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