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Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas

Glioblastoma Clinical Trial

Official title:
Phase I/II Study of the Tolerability, Safety, and Efficacy of Liposomal Curcumin in Combination With Radiation and Temozolomide in Patients With Newly Diagnosed High-Grade Gliomas

Clinical Trial Summary

The objective of this study is to assess the tolerability, safety, and efficacy of Liposomal Curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) in patients with newly diagnosed High-Grade Gliomas (HGG).

Clinical Trial Description

This study is a Phase 1/2, single-center, single-institution, open-label, dose-escalation study in patients with newly diagnosed high-grade malignant gliomas. Dose finding will be performed using a time-to-event Bayesian optimal interval (TITE-BOIN) rule-based schema. The primary objectives of the study are to determine the maximum tolerated dose /recommended phase 2 dose of Liposomal Curcumin (LC) in combination with radiotherapy (RT), and TMZ and adjuvant TMZ in newly diagnosed High-Grade Gliomas, and to determine the safety and tolerability of LC IV infused over 3-hours. The secondary objectives are to estimate the safety and tolerability of LC in combination with standard RT and TMZ and adjuvant TMZ, to determine the feasibility of weekly LC infusion, defined as the number of patients being able to complete 80% of the planned doses of LC, 80% of RT, and 60% of TMZ within the first 10 weeks of treatment, and to assess efficacy as defined by overall survival (OS) and progression free survival (PFS) observed for each dose level. This study is an unblinded, sequential treatment intervention employing 3 dose levels. Approximately 50 patients will be screened to achieve up to 30 patients assigned to study intervention. The duration of treatment for each patient will be up to 34 weeks. Treatment starts with the beginning of infusion and ends, if tolerated, at the end of Cycle 6 of adjuvant TMZ. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05768919
Study type Interventional
Source SignPath Pharma, Inc.
Contact Vice President Regulatory Affairs and Operations
Phone 801-557-1214
Email mcomas@signpathpharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 3, 2023
Completion date May 2027
View Details
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