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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• 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).

• 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).

• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Ashish Shah, MD
ashah@med.miami.edu
(305) 243-6946
Backup
Macarena De La Fuente, MD
MDelaFuente@med.miami.edu
(305) 243-2858
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 24
Treatments
Experimental: Part 1: STARLITE Dose Escalation/De-Escalation Cohort
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.
Experimental: Part 2: STARLITE Dose Expansion Cohort
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.
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic
Leads: University of Miami

This content was sourced from clinicaltrials.gov

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