Study on Retifanlimab With or Without DFMO for Treating Progressive High Grade Gliomas

Inclusion Criteria

• Must be 18 years or older.
• Diagnosed with high-grade glioma, such as:
  • Glioblastoma, IDH-wild type
  • Grade 3 or 4 IDH1/2 mutant astrocytoma
  • Grade 3 oligodendroglioma
  • Any prior grade 2 astrocytoma or oligodendroglioma suspected to have returned at a higher grade
  • Other high-grade glioma
• Planning to have surgery as part of regular care.
• Tumor is growing or spreading, confirmed by scans.
• Tumor can be measured by scans.
• In good general health with a performance status score of 0, 1, or 2.
• Blood tests showing:
  • Hemoglobin level of at least 9.0 g/dL
  • Neutrophil count of at least 1500/mm³
  • Platelet count of at least 100,000/mm³
  • Total bilirubin level within 1.5 times the normal limit
  • Liver enzymes (ALT and AST) within 3 times the normal limit (or 5 times if liver is involved)
  • Kidney function with creatinine clearance of at least 45 ml/min
• Negative pregnancy test for those who can become pregnant.
• Willing to provide consent for tissue and blood sample storage.
• Able to complete forms with or without help.
• Willing to return for follow-up visits during the study.

Exclusion Criteria

• Pregnant or nursing individuals, or those who can become pregnant or father a child and are not using effective birth control.
• Uncontrolled illnesses that could interfere with the study, such as:
  • Active infections needing treatment
  • Lung diseases requiring steroids
  • Autoimmune diseases needing treatment in the past 2 years
  • Heart failure or unstable chest pain
  • Mental health issues affecting study participation
  • Active Hepatitis B or C infections
• Recent heart attack or severe heart disease.
• History of stem cell transplant.
• Taking other experimental treatments.
• Unable to swallow the DFMO solution or have conditions affecting medication absorption.
• Allergic to DFMO or retifanlimab.
• Cannot undergo MRI or receive gadolinium.