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I-131-CLR1404 Injection

Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma

Ensayo de Cellectar Biosciences, Inc. en Glioma.

Más ensayos de: Glioma.

Fase

Fase 2

Estado

Retirado antes de empezar

Centros

1

Fin del objetivo primario

jun 2014

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2014.

Qué mide

Evaluate the 6-month survival rate of subjects receiving I-131-CLR1404 for relapsed glioma (del registro, en inglés) (6 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de CLRB

Todos los de CLRB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01778088), actualizada en feb 2014.