High Grade GliomaPhase 1STARLITENCT06428045
STARLITE for Unresectable High-Grade Gliomas
A Phase 1 study testing Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT), Abacavir and Lamivudine in people with High Grade Glioma, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT), Abacavir and Lamivudine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 30 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.
- For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1).
- 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.
- Preoperative Karnofsky score ≥ 70 (APPENDIX A).
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- Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
- Blood urea nitrogen (BUN) ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate > 50 mL per minute.
- Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
- Prothrombin time (PT)/International Normalized Ratio (INR) <1.4
- Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
- Sodium level > 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
- Patients must be able to understand and sign informed consent.
Who cannot join
- 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.
- Patients who have received any surgical resection for this tumor.
- Patients who have received an open biopsy for this disease are still eligible for participation.
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- Patients who have received chemotherapy or radiation for this disease.
- Patients who are taking dofetilide (Section 4.10.1).
- 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.
- Patients not eligible to obtain MRI with and without contrast.
- Recurrent HGG.
- Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
- Fever within 48 hours of surgery (Temperature> 38.0°C).
- Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
- Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
- Pregnant women.
- Patients must be willing to use contraception as described in Section 4.11.
- Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
- Prisoners.
- Adults unable to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Ashish Shah, MD, (305) 243-6946, ashah@med.miami.edu
Macarena De La Fuente, MD, (305) 243-2858, MDelaFuente@med.miami.edu
About this study
Official title: Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
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
- Being tested
- Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT), Abacavir, Lamivudine, Ritonavir, Temozolomide
- Keywords
- Unresectable High Grade Glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)Procedure or surgery
Also called MR-Guided LITT
Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy.
AbacavirDrug
Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).
LamivudineDrug
Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)
RitonavirDrug
Also called Norvir, RTV
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
TemozolomideDrug
Also called TMZ
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 RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: STARLITE Dose Escalation/De-Escalation Cohort | Experimental | 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. Receives: Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT); Drug: Abacavir; Drug: Lamivudine; Drug: Ritonavir; Drug: Temozolomide; Radiation: Focal Radiotherapy |
| Part 2: STARLITE Dose Expansion Cohort | Experimental | 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. Receives: Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT); Drug: Abacavir; Drug: Lamivudine; Drug: Ritonavir; Drug: Temozolomide; Radiation: Focal Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 28 days
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).
Measured: Up to 12 months
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as percentage of participants without disease progression at time of study discontinuation.
Measured: Up to 24 months
Overall Survival (OS)
Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Apr 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose escalation/de-escalation and dose expansion design.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Ashish Shah, University of Miami
- Investigators
- Ashish Shah, MD, Principal investigator, University of MiamiMacarena De La Fuente, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428045
- Sponsor's protocol ID
- 20231163
- Acronym
- STARLITE
- Status last verified
- Jun 2026
- First submitted
- 20 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Daftari M, Ramsoomair CK, Aaronson D, Seetharam D, Andreae EA, Wright L, Han S, Chandar J, Lu V, Govindarajan V, Ivan ME, Komotar RJ, de la Fuente M, Shah AH. Synergistic Treatment with Antiretrovirals and Laser Interstitial Thermal ThErapy (STARLITE) for unresectable glioblastoma: A phase 1 study protocol. PLoS One. 2025 Aug 28;20(8):e0328204. doi: 10.1371/journal.pone.0328204. eCollection 2025.
PubMed 40875628
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
- ClinicalTrials.gov ID
- NCT06428045
- Acronym / sponsor ID
- STARLITE / 20231163
- Conditions
- High Grade Glioma
- Keywords
- Unresectable High Grade Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 dose escalation/de-escalation and dose expansion design.
| Arm | Type | Receives |
|---|---|---|
| Part 1: STARLITE Dose Escalation/De-Escalation Cohort | Experimental | Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT), Drug: Abacavir, Drug: Lamivudine, Drug: Ritonavir, Drug: Temozolomide, Radiation: Focal RadiotherapyParticipants 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. |
| Part 2: STARLITE Dose Expansion Cohort | Experimental | Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT), Drug: Abacavir, Drug: Lamivudine, Drug: Ritonavir, Drug: Temozolomide, Radiation: Focal RadiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Preoperative Karnofsky score ≥ 70 (APPENDIX A).
Key exclusion criteria (20 listed)
- 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.
- Patients who have received any surgical resection for this tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)Also: MR-Guided LITTParticipants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy. | Procedure or surgery | Part 1: STARLITE Dose Escalation/De-Escalation Cohort, Part 2: STARLITE Dose Expansion Cohort |
| AbacavirParticipants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART). | Drug | Part 1: STARLITE Dose Escalation/De-Escalation Cohort, Part 2: STARLITE Dose Expansion Cohort |
| LamivudineParticipants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART) | Drug | Part 1: STARLITE Dose Escalation/De-Escalation Cohort, Part 2: STARLITE Dose Expansion Cohort |
| RitonavirAlso: Norvir, RTVParticipants 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 | Part 1: STARLITE Dose Escalation/De-Escalation Cohort, Part 2: STARLITE Dose Expansion Cohort |
| TemozolomideAlso: TMZParticipants 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. | Drug | Part 1: STARLITE Dose Escalation/De-Escalation Cohort, Part 2: STARLITE Dose Expansion Cohort |
| Focal RadiotherapyParticipants 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. | Radiation | Part 1: STARLITE Dose Escalation/De-Escalation Cohort, Part 2: STARLITE Dose Expansion Cohort |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicity
Time frame: Up to 28 days
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).
Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events
Time frame: Up to 12 months
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).
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 40875628Daftari M, Ramsoomair CK, Aaronson D, Seetharam D, Andreae EA, Wright L, Han S, Chandar J, Lu V, Govindarajan V, Ivan ME, Komotar RJ, de la Fuente M, Shah AH. Synergistic Treatment with Antiretrovirals and Laser Interstitial Thermal ThErapy (STARLITE) for unresectable glioblastoma: A phase 1 study protocol. PLoS One. 2025 Aug 28;20(8):e0328204. doi: 10.1371/journal.pone.0328204. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashish Shah, MD principal investigator
University of Miami
Macarena De La Fuente, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT), Abacavir and Lamivudine in people with High Grade Glioma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashish Shah, MD ((305) 243-6946, ashah@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-Limiting Toxicity (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.