STARLITE for Unresectable High-Grade Gliomas

Phase 1 Recruiting 24 enrolled University of Miami Medtronic · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2025-04-15
Primary completion: 2029-04-30
Completion: 2030-04-30

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ritonavir	Other / unclassified	100 mg	Oral
Subject	Ritonavir	Other / unclassified	300 mg	Oral
Subject	Ritonavir	Other / unclassified	400 mg	Oral
Subject	Ritonavir	Other / unclassified	600 mg	Oral
Background	Abacavir	Other / unclassified	600 mg	Oral
Background	Lamivudine	Other / unclassified	300 mg	Oral
Background	Temozolomide	Small molecule	200 mg/m2	Oral

STARLITE for Unresectable High-Grade Gliomas

Summary

Timeline

Publications

Drugs

Indications