About this trial
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 criteria
Qualifiers
Age ≥ 18 years
Glioblastoma, IDH-wild type (WT)
Grade 3 or 4 IDH1/2 mutant astrocytoma or
Grade 3 oligodendroglioma
Disqualifiers
Pregnant persons
Nursing persons
Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Eflornithine
- Lumbar Puncture
- Magnetic Resonance Imaging
- Retifanlimab
- Tumor Resection