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Clinical Trial Summary

In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.


Clinical Trial Description

The aim of this study is to identify the safety profile and the recommended dose for phase 2 study of the combination of indoximod (portion 1, phase 1b study). Investigators will then evaluate the tolerability and the preliminary activity in patients with recurrent GBM in three different situations: - Combination of indoximod and temozolomide (bevacizumab-naive patients) - Combination of indoximod and temozolomide in patients currently receiving or having received and failed bevacizumab. - Combination of indoximod and temozolomide with stereotactic radiation. Ancillary studies will be conducted to assess the correlation between intra-tumoral IDO expression or serum biomarkers (immune monitoring) and treatment efficacy. If the current study shows an acceptable safety profile and suggests preliminary evidence of activity, this will provide the justification for subsequent randomized phase 2 studies in refractory glioblastoma multiforme (GBM). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02052648
Study type Interventional
Source Lumos Pharma
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2014
Completion date June 20, 2019

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