Clinical Trial

Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

Recruiting Phase 1/2

Record status

This record was last updated March 26, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Summary

This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.

Protocol Amendment History 30 amendments

This ClinicalTrials.gov record has been amended 30 times since 2013-07-19; most recent amendment 2025-03-25.

Status change: Not Yet Recruiting → Recruiting 2015-03-13

Trial Details

NCT Number	NCT01906385
Lead Sponsor	Plus Therapeutics Collaborators: National Cancer Institute (NCI)
Conditions	Glioma
Enrollment	55 participants
Start Date	2015-06-03
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-26