Overview
The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years.
- Patients with a histologically confirmed or suspected high-grade glioma (HGG) by
MRI.
- 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.
- 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.