Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

Trial ID: NCT06428045

Interventional - Phase 1 - Recruiting

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.

Conditions

• High Grade Glioma

Interventions

• Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
• Abacavir
• Lamivudine
• Ritonavir
• Temozolomide
• Focal Radiotherapy

Eligibility

Inclusion criteria

• 1. Age ≥ 18 years.
• 2. 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).
• 3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
• 4. 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.
• 5. Preoperative Karnofsky score ≥ 70 (APPENDIX A).
• 6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
• 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
• 2. Platelets ≥ 100,000 cells/mm3
• 3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
• 4. 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.
• 5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
• 6. Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4
• 7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
• 8. Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
• 7. Patients must be able to understand and sign informed consent.

Exclusion criteria

• 1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7).
• 2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
• 3. Patients with a previous history of HIV infection.
• 4. Patients with uncontrolled hepatitis B or C infection.
• 5. 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.
• 6. Patients who have received chemotherapy or radiation for this disease.
• 7. Patients who are taking dofetilide (Section 4.10.1).
• 8. 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.
• 9. Patients not eligible to obtain MRI with and without contrast.
• 10. Recurrent HGG.
• 11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
• 12. Fever within 48 hours of surgery (Temperature\> 38.0°C).
• 13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
• 14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
• 15. Pregnant women.
• 16. Patients must be willing to use contraception as described in Section 4.11.
• 17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
• 18. Prisoners.
• 19. Adults unable to consent.

Sponsor

University of Miami, Medtronic

Source: ClinicalTrials.gov

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