STARLITE for Unresectable High-Grade Gliomas

Inclusion criteria

• Age ≥ 18 years.
• Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.

a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1).

• Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
• Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists.
• Preoperative Karnofsky score ≥ 70 (APPENDIX A).
• Patients must have demonstrable normal organ function as defined below within 14 days of surgery.

• Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
• Blood urea nitrogen (BUN) ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate > 50 mL per minute.
• Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
• Prothrombin time (PT)/International Normalized Ratio (INR) <1.4
• Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
• Sodium level > 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
• Patients must be able to understand and sign informed consent.

Exclusion criteria

• Patients with human leukocyte antigen (HLA) HLA-B*5701 hypersensitivity (Section 10.1.6.7).
• Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
• Patients with a previous history of HIV infection.
• Patients with uncontrolled hepatitis B or C infection.
• Patients who have received any surgical resection for this tumor.

a. Patients who have received an open biopsy for this disease are still eligible for participation.

• Patients who have received chemotherapy or radiation for this disease.
• Patients who are taking dofetilide (Section 4.10.1).
• Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10.
• Patients not eligible to obtain MRI with and without contrast.
• Recurrent HGG.
• Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
• Fever within 48 hours of surgery (Temperature> 38.0°C).
• Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
• Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
• Pregnant women.
• Patients must be willing to use contraception as described in Section 4.11.
• Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
• Prisoners.
• Adults unable to consent.