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NCT02502708 · ClinicalTrials.gov registry record · Phase 1
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT02502708 is a Phase 1 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 81 participants.
The verdict
NCT02502708, a Phase 1 study, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Cyclophosphamide
- DRUG Temozolomide
- DRUG Etoposide
- DRUG Indoximod
- RADIATION Conformal Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02502708
The ClinicalTrials.gov registry entry for NCT02502708 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02502708 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02502708 about?
NCT02502708 is a clinical study titled "Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors". 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-...
What is the current status of trial NCT02502708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2015-10. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT02502708?
The interventions under investigation include: Cyclophosphamide (DRUG), Temozolomide (DRUG), Etoposide (DRUG), Indoximod (DRUG), Conformal Radiation (RADIATION).
Who is sponsoring clinical trial NCT02502708?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
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