Phase I/IIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma
Mayo Clinic
Summary
This phase I/II trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and/or effective in treating patients with progressive high grade glioma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of high-grade glioma, including any of the following: * Glioblastoma, IDH-wild type (WT) * Grade 3 or 4 IDH1/2 mutant astrocytoma or * Grade 3 oligodendroglioma * Any prior grade 2 astrocytoma or oligodendroglioma that is suspected to have recurred at a higher grade * Other high-grade glioma * Plan for surgical resection as part of routine clinical care * Radiographic disease progression, with or without tissue confirmation * Measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 and Karno…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and CSF collection
- DrugEflornithine
Given PO
- ProcedureLumbar Puncture
Undergo lumbar puncture
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalRetifanlimab
Given IV
- ProcedureTumor Resection
Undergo resection surgery
Location
- Mayo Clinic in RochesterRochester, Minnesota