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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Eden Medical Center
Castro Valley, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects
Number of RLTs observed in each dose level.
Time frame: 3 months
Phase 2: Number of Phase 1 Participants With Efficacy Outcomes
Six-month progression-free survival.
Time frame: 6 months
Overall Response Rate for Phase 2 Participants
Subjects with a complete response or partial response by RANO assessment. Overall Response Rate was only assessed in phase 2 subjects on this trial.
Time frame: 18 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Number of subjects with at least 1 treatment emergent adverse event.
Time frame: 18 Months
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