Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
Completed · Phase 1
Conditions studied: Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor, Ependymoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Primary CNS Tumor
In brief
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.
Key facts
- Study ID
- NCT02502708
- Run by
- NewLink Genetics Corporation
- People needed
- 81
- Starts
- 2015-10-01
- Expected to finish
- 2020-02-28
- Last updated by the study team
- 2020-06-04
Who can join
Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Prior invasive malignancy, other than the primary central nervous system tumor, unless the patient has been disease free and off therapy for that disease for a minimum of 3 years
- Patients with baseline QTc interval of more than 470 msec at study entry, and patients with congenital long QTc syndrome.
- Active autoimmune disease
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
- Arnold Palmer Hospital for Children — Orlando, Florida, United States
- Children's Heathcare of Atlanta — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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