Antiretrovirals and Laser Interstitial Thermal Therapy for the Treatment of Newly Diagnosed Unresectable High-Grade Gliomas, STARLITE Trial

Inclusion Criteria

• Age ≥ 18 years
• Patients with a histologically confirmed or suspected HGG by MRI * For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists * HGG for this study include IDH wild-type gliomas including glioblastoma and molecular glioblastoma multiforme (GBM) (low-grade glioma on histology with molecular features of GBM)
• 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
• Absolute neutrophil count (ANC) ≥ 1500 cells/mm^3 (within 14 days of surgery)
• Platelets ≥ 100,000 cells/mm^3 (within 14 days of surgery)
• Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable (within 14 days of surgery)
• 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 (within 14 days of surgery)
• Electrocardiogram (ECG) without evidence of acute cardiac ischemia (within 14 days of surgery)
• Prothrombin time (PT)/international normalized ratio (INR) < 1.4 (within 14 days of surgery)
• Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN) (within 14 days of surgery)
• Sodium level > 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable (within 14 days of surgery)
• Patients must be able to understand and sign informed consent

Exclusion Criteria

• Patients with HLA-B*5701 hypersensitivity * NOTE: patients with a pending HLA-B test result may still undergo the LITT procedure as part of their standard medical care. However, the HLA-B test result must be obtained prior to a participant starting ART as part of this study
• Patients with sensitivity to abacavir, lamivudine, or ritonavir
• 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 * 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
• Patients on a regimen of 1 or more prohibited medications that cannot be discontinued or switched to a more compatible medication
• 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
• Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial
• Prisoners
• Adults unable to consent