Clinical Research Directory
Browse clinical research sites, groups, and studies.
STARLITE for Unresectable High-Grade Gliomas
Sponsor: University of Miami
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.
Official title: Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-04-15
Completion Date
2030-04-30
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
Magnetic 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.
Abacavir
Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).
Lamivudine
Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)
Ritonavir
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
Temozolomide
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.
Focal 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.
Locations (1)
University of Miami
Miami, Florida, United States