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

NCT01906385 ↗

Phase 1/2 Recruiting 55 enrolled Plus Therapeutics National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2015-06-03
Primary completion: 2025-12
Completion: 2025-12

Publications

Wu C, Hormuth DA 2nd, Christenson CD, Woodall RT, Abdelmalik MRA, Phillips WT, Hughes TJR, Brenner AJ, Yankeelov TE. Image-guided patient-specific optimization of catheter placement for convection-enhanced nanoparticle delivery in recurrent glioblastoma. Comput Biol Med. 2024 Sep;179:108889. doi: 10.1016/j.compbiomed.2024.108889. Epub 2024 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rhenium Liposome Treatment	Other / unclassified	1 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	2 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	4 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	8 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	13.4 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	22.3 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	31.2 unknown	Other
Subject	Rhenium Liposome Treatment	Other / unclassified	41.5 unknown	Other

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

Summary

Timeline

Publications

Drugs

Indications