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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2a, Multi-Center, Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma|
- Evaluate the 6-month survival rate of subjects receiving I-131-CLR1404 for relapsed glioma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Drug: I-131-CLR1404 Injection
Other Name: 18-(p-[I-131]-iodophenyl)octadecyl phosphocholine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778088
|United States, Maryland|
|University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Minesh Mehta, M.D., FASTRO||University of Marylannd School of Medicine|