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NCT06428045 · ClinicalTrials.gov registry record · Phase 1
STARLITE for Unresectable High-Grade Gliomas
A Phase 1 study of High Grade Glioma, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06428045: Recruiting Phase 1 study of High Grade Glioma, sponsored by University of Miami.
NCT06428045 is a Phase 1 study of High Grade Glioma that is actively recruiting participants, run by University of Miami. The registered enrollment target is 24 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06428045, a Phase 1 study of High Grade Glioma, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Temozolomide
- PROCEDURE Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
- DRUG Abacavir
- DRUG Lamivudine
- DRUG Ritonavir
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 1 |
What NCT06428045 shows while recruiting
NCT06428045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (63% lower).
The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT06428045 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06428045 about?
NCT06428045 is a clinical study titled "STARLITE for Unresectable High-Grade Gliomas". 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-grad...
What is the current status of trial NCT06428045?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-04-15. Estimated completion is 2030-04-30.
What conditions does trial NCT06428045 study?
This clinical trial studies the following conditions: High Grade Glioma.
What interventions are being tested in trial NCT06428045?
The interventions under investigation include: Temozolomide (DRUG), Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT) (PROCEDURE), Abacavir (DRUG), Lamivudine (DRUG), Ritonavir (DRUG).
Who is sponsoring clinical trial NCT06428045?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06428045 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06428045's enrollment target sits among peer trials
24 29th of 42 higher than 14 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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