Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
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Clinical Trial Information
Trial Contact: Dubberly, Paige D; Armatti, Julie M; Doyle, Katherine M; Parker, Melanie
Trial Phone: 321-841-7561 ; 321-843-5284 ; 3218412008 ; 321-843-1036
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IRB No: S23.109.06
Protocol Abbrev: OKN-007-EA-DMG
Principal Investigator: Amy A. Smith, MD
Age Group: Pediatric
ClinicalTrials.gov ID: NCT05518838
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Objective
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.
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Key Eligibility
- Age from > 12 months to ≤ 18 years of age at the time of enrollment.
- Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
- Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
