The safety and tolerability of multiple doses of intravenously (IV) administered 131I-TM601 in adult patients with progressive and/or recurrent malignant glioma with measurable disease. Safety will be evaluated throughout the treatment and follow-up phase for all study patients; dose escalation decisions will be based on safety experience for each patient at 21 days following the final treament dose. [clinicaltrials_resource:89912f361e0e4ebfe3cd2a776381cdca]
In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.
clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]
The safety and tolerability of multiple doses of intravenously (IV) administered 131I-TM601 in adult patients with progressive and/or recurrent malignant glioma with measurable disease. Safety will be evaluated throughout the treatment and follow-up phase for all study patients; dose escalation decisions will be based on safety experience for each patient at 21 days following the final treament dose. [clinicaltrials_resource:89912f361e0e4ebfe3cd2a776381cdca]
In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.
Bio2RDF identifier
89912f361e0e4ebfe3cd2a776381cdca
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:89912f361e0e4ebfe3cd2a776381cdca
measure [clinicaltrials_vocabulary:measure]
The safety and tolerability of ...... lioma with measurable disease.
time frame [clinicaltrials_vocabulary:time-frame]
Safety will be evaluated throu ...... owing the final treament dose.
description
In the first study phase (Dose ...... ivity per infusion is 100 mCi.
identifier
clinicaltrials_resource:89912f361e0e4ebfe3cd2a776381cdca
title
The safety and tolerability of ...... owing the final treament dose.
@en
type
label
The safety and tolerability of ...... 12f361e0e4ebfe3cd2a776381cdca]
@en