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STARLITE for Unresectable High-Grade Gliomas | Clinical Trials | Clareo Health

RECRUITINGPHASE1

STARLITE for Unresectable High-Grade Gliomas

Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

NCT06428045•University of Miami

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years.
•2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.
•a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1).
•3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
•4. Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists.
•5. Preoperative Karnofsky score ≥ 70 (APPENDIX A).
•6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
•1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
•2. Platelets ≥ 100,000 cells/mm3
•3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
+6 more criteria

Exclusion Criteria

•1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7).
•2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
•3. Patients with a previous history of HIV infection.
•4. Patients with uncontrolled hepatitis B or C infection.
•5. Patients who have received any surgical resection for this tumor.
•a. Patients who have received an open biopsy for this disease are still eligible for participation.
•6. Patients who have received chemotherapy or radiation for this disease.
•7. Patients who are taking dofetilide (Section 4.10.1).
•8. Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10.
•10. Recurrent HGG.
+9 more criteria

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

April 15, 2025

Primary Completion Date

April 30, 2029

Completion Date

April 30, 2030

Last Updated

June 22, 2025

Enrollment

ESTIMATED participants

Conditions

High Grade Glioma

Interventions

Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)

PROCEDURE

Abacavir

DRUG

Lamivudine

DRUG

Ritonavir

DRUG

Temozolomide

DRUG

Focal Radiotherapy

RADIATION

Contacts

Ashish Shah, MD

CONTACT

(305) 243-6946 ashah@med.miami.edu

Macarena De La Fuente, MD

CONTACT

(305) 243-2858 MDelaFuente@med.miami.edu

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGNA

A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery

NCT07042620

Brain Tumor AdultLow Grade Glioma (LGG), High Grade Glioma (HGG)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

STARLITE for Unresectable High-Grade Gliomas

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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