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STARLITE for Unresectable High-Grade Gliomas

ConditionHigh Grade Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

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

Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.

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.

Disqualifiers

Patients with human leukocyte antigen (HLA) HLA-B*5701 hypersensitivity (Section 10.1.6.7).

Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).

Patients with a previous history of HIV infection.

Patients with uncontrolled hepatitis B or C infection.

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Procedure/Surgery

    Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy.

  • Abacavir

    Drug

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

  • Lamivudine

    Drug

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

  • Ritonavir

    Drug

    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

  • Temozolomide

    Drug

    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.

  • Focal Radiotherapy

    Radiation

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Part 1: STARLITE Dose Escalation/De-Escalation CohortExperimental treatment 6 interventions
Group B: Part 2: STARLITE Dose Expansion CohortExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Dose-Limiting Toxicity

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).

Time frame
Up to 28 days
2

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

The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs 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).

Time frame
Up to 12 months

Secondary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as percentage of participants without disease progression at time of study discontinuation.

Time frame
Up to 24 months
2

Overall Survival (OS)

Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov
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