STARLITE for Unresectable High-Grade Gliomas
This study is looking at a new way to treat high-grade gliomas (a type of brain tumor) that cannot be removed by surgery. It combines a procedure called MR-guided Laser Interstitial Thermal Therapy (LITT), which uses a laser to heat and destroy tumor cells, with several medications: Abacavir, Lamivudine, and Ritonavir (part of a combination anti-HIV therapy), and Temozolomide (a standard chemotherapy drug). Researchers want to see if this combination changes the tumor and to understand any side effects. You might be able to join if you are 18 or older and have a newly diagnosed high-grade glioma that cannot be surgically removed. The study will enroll 24 participants and will measure side effects for up to 12 months to determine success.
- Study design
- This study is an interventional study with a planned enrollment of 24 participants. The phase is not specified, and the status is unclear.
- What's involved
- You would receive MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure. You would also take Abacavir, Lamivudine, Ritonavir, and Temozolomide orally as directed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track serious and high-grade adverse events for up to 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
STARLITE for Unresectable High-Grade Gliomas
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ashish Shah, MD · PRINCIPAL_INVESTIGATOR · University of Miami
- Macarena De La Fuente, MD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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What this trial measures
- Number of Participants Experiencing Dose-Limiting ToxicityUp to 28 days
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).
- Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse EventsUp to 12 months
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).