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Antiretroviral

STARLITE for Unresectable Brain Tumors (STARLITE Trial)

Phase 1

Waitlist Available

Led By Ashish Shah, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI

Age ≥ 18 years

Must not have

Patients with sensitivity to abacavir, lamivudine, or ritonavir

Patients with human leukocyte antigen (HLA) HLA-B*5701 hypersensitivity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Summary

This trial aims to see if the treatment can help high-grade glioma that cannot be removed by surgery and to understand the side effects of the treatment in patients with this type of brain tumor.

Who is the study for?

This trial is for individuals with newly diagnosed high-grade gliomas (a type of brain tumor) that cannot be surgically removed. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may have restrictions based on other medical treatments or conditions.

What is being tested?

The STARLITE trial tests a combination of therapies: MR-guided Laser Interstitial Thermal Therapy (LITT), antiviral drugs Abacavir, Lamivudine, Ritonavir, Focal Radiotherapy, and the chemotherapy drug Temozolomide to see how they affect inoperable high-grade gliomas.

What are the potential side effects?

Potential side effects could include tissue damage from heat during LITT, reactions to antiviral medications like nausea or fatigue, skin irritation from radiotherapy, and typical chemotherapy-related issues such as hair loss or lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My MRI suggests I have a high-grade brain tumor.

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I am 18 years old or older.

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My brain tumor can be mostly removed by surgery, as determined by my surgeon.

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My diagnosis of high-grade glioma was confirmed during surgery.

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I am mostly able to care for myself and carry out normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to abacavir, lamivudine, or ritonavir.

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I am allergic to the HLA-B*5701 protein.

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I do not have uncontrolled hepatitis B or C.

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I have had surgery to remove my tumor.

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I am not taking any medications that are not allowed in the study.

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I am unable to give consent for myself.

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I am currently taking dofetilide.

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My high-grade glioma has come back.

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I currently have a serious infection like sepsis or pneumonia.

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I have received chemotherapy or radiation for my condition.

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I have a serious health condition that makes cancer treatment too risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Experiencing Dose-Limiting Toxicity

Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events

Secondary study objectives

Overall Survival (OS)

Progression-Free Survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: STARLITE Dose Expansion CohortExperimental Treatment6 Interventions

Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) after biopsy on Day 0. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and the recommended phase 2 dose (RP2D) of Ritonavir determined in Part 1. Participants will receive up to 12 months of ART. Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days), and Temozolomide therapy, during and following radiotherapy up to Day 180. Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months. Total participation is approximately two years.

Group II: Part 1: STARLITE Dose Escalation/De-Escalation CohortExperimental Treatment6 Interventions

Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) on Day 0 after stereotactic needle biopsy. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and dose escalation/de-escalation of Ritonavir (RTV), to determine the recommended Phase 2 dose (RP2D) of Ritonavir. Participants will receive up to 12 months of ART. Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days). Participants will be administered Temozolomide up to Day 180. Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abacavir

2005

Completed Phase 4

~1410

Lamivudine

2006

Completed Phase 4

~8120

Ritonavir

2005

Completed Phase 4

~2200

Temozolomide

2010

Completed Phase 3

~1880

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

935 Previous Clinical Trials

422,193 Total Patients Enrolled

MedtronicIndustry Sponsor

613 Previous Clinical Trials

759,709 Total Patients Enrolled

Ashish Shah, MDPrincipal InvestigatorUniversity of Miami

2 Previous Clinical Trials

33 Total Patients Enrolled

~16 spots leftby May 2028

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