Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
Summary
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.
Arms & interventions
- ProcedureMagnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy.
- DrugAbacavir
Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).
- DrugLamivudine
Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)
- DrugRitonavir
Participants will take one tablet of Ritonavir (RTV) orally twice daily, as part of combination antiretroviral therapy (ART), at one of the following dose levels: * Dose Level 1: 100mg * Dose Level 2 (starting dose): 300mg * Dose Level 3: 400mg * Dose Level 4: 600mg
- DrugTemozolomide
Participants will take Temozolomide (TMZ) via capsule orally, during and after focal radiotherapy, as part of standard of care adjuvant therapy. During focal radiotherapy, Temozolomide will be administered at a dose of 75 mg/m2 once daily for six weeks (42 days) on a continuous dosing regimen, including weekends and holidays. After completion of focal radiotherapy, Temozolomide will be administered at 150 mg/m\^2 on days 1 through 5 of Cycle 1, and at 200 mg/m\^2 on days 1 through 5 of Cycles 2 through 6, for a total of six 28-day cycles of maintenance therapy.
- RadiationFocal Radiotherapy
Participants will be administered focal radiotherapy for six weeks (42 days), as part of adjuvant therapy, at a total dose of 50-60 grays (Gy) in 1.8-2.0 Gy fractions, depending on prognosis and as determined by the treating radiation oncologist.
Outcome measures
Primary
Number of Participants Experiencing Dose-Limiting Toxicity
The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Time frame: Up to 28 days
Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events
The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Time frame: Up to 12 months
Secondary
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Eligibility criteria
Study locations (1)
University of Miami
Miami, Florida, 33136
References
- Daftari M, Ramsoomair CK, Aaronson D, Seetharam D, Andreae EA, Wright L, Han S, Chandar J, Lu V, Govindarajan V, Ivan ME, Komotar RJ, de la Fuente M, Shah AH. Synergistic Treatment with Antiretrovirals and Laser Interstitial Thermal ThErapy (STARLITE) for unresectable glioblastoma: A phase 1 study protocol. PLoS One. 2025 Aug 28;20(8):e0328204. doi: 10.1371/journal.pone.0328204. eCollection 2025.(PubMed)