Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors

ClinicalTrials.gov ID: NCT02502708

Public ClinicalTrials.gov record NCT02502708. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:15 PM EDT

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Official title

A Phase I Trial of Indoximod and Temozolomide-Based Therapy for Children With Progressive Primary Brain Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation significantly enhanced survival by driving a vigorous, tumordirected inflammatory response. This data provided the rationale for the companion adult phase 1 trial using indoximod (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the clinic for children with brain tumors. This study will provide a foundation for future pediatric trials testing indoximod combined with radiation and temozolomide in the up-front setting for patients with newly diagnosed central nervous system tumors.

Study identification

NCT ID: NCT02502708
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: NewLink Genetics Corporation; Industry
Enrollment: 81 participants

Conditions and interventions

Conditions

Interventions

Drug · Radiation

Eligibility (public fields only)

Age range: 3 Years to 21 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2015 (Type not available)
Primary completion: Dec 12, 2019 (Actual)
Completion: Feb 28, 2020 (Actual)
Last update posted: Jun 4, 2020

2015 – 2020

United States locations

U.S. sites: 5
U.S. states: 4
U.S. cities: 5

Facility	City	State	ZIP	Site status
Children's Hospital Colorado	Aurora	Colorado	80045	—
Arnold Palmer Hospital for Children	Orlando	Florida	32806	—
Children's Heathcare of Atlanta	Atlanta	Georgia	30342	—
Augusta University	Augusta	Georgia	30912	—
Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota	55404	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02502708, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 4, 2020 · Synced Oct 19, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT02502708 live on ClinicalTrials.gov.

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