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BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma — 329  

Glioblastoma Clinical Trial

Official title:
BrUOG 329: Onivyde (Nanoliposomal Irinotecan) and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: A Phase IB/IIA Brown University Oncology Research Group Study

Clinical Trial Summary

New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I study will establish the MTD of the combination of nanoliposomal irinotecan in combination with temozolomide safety and preliminary clinical efficacy of the combination of nanoliposomal irinotecan and metronomic temozolomide.

Clinical Trial Description

1.1 Primary Objective 1.1.1. To evaluate the maximum tolerated dose of nanoliposomal irinotecan with continuous low-dose temozolomide for patients with recurrent glioblastoma. 1.1.2 To assess the preliminary response rate and progression free survival of nanaliposomal irinotecan with continuous low-dose temozolomide in patients with recurrent glioblastoma. 1.2 Secondary Objectives 1.2.1 To evaluate the safety of nanoliposomal irinotecan with continuous low-dose temozolomide. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03119064
Study type Interventional
Source Brown University
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date November 30, 2017
Completion date October 8, 2021
View Details
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