STARLITE for Unresectable High-Grade Gliomas

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.

Conditions

• High Grade Glioma

Interventions

PROCEDURE

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.

DRUG

Abacavir

Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).

DRUG

Lamivudine

Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)

DRUG

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

DRUG

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.

RADIATION

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.

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• University of Miami

  lead OTHER

Principal Investigators

• Ashish Shah, MD · University of Miami

• Macarena De La Fuente, MD · University of Miami

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2029-04-30

Completion

2030-04-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations