NCT02052648

Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

A Phase I/II Study of the Combination of Indoximod and Temozolomide for Adult Patients With Temozolomide-Refractory Primary Malignant Brain Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Glioblastoma Multiforme
• Glioma
• Gliosarcoma
• Malignant Brain Tumor

Interventions

Type	Name	Description
DRUG	Indoximod
DRUG	Temozolomide
DRUG	Bevacizumab
RADIATION	Stereotactic Radiation

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-04-18
• Completion: 2019-06-20
• First posted: 2014-02-03
• Last updated: 2024-03-27
• Results posted: 2024-03-27

Locations

17 sites across 1 country: United States