Treatment for inoperable high-grade brain tumors

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

This study is testing a new treatment that combines laser therapy and medications to see if it can help people with inoperable high-grade brain tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06428045 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of a combination treatment involving Magnetic Resonance-guided Laser Interstitial Thermal Therapy (LITT) and various medications on patients with newly diagnosed high-grade gliomas that cannot be surgically removed. The study will assess changes in the tumors and identify potential side effects of the treatment. Participants will undergo treatment while being closely monitored for their response and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed or suspected high-grade gliomas that are deemed inoperable or high-risk for surgical resection.

Not a fit: Patients with low Karnofsky scores or those with other significant health issues that prevent them from undergoing the treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with inoperable high-grade gliomas, potentially improving survival and quality of life.

How similar studies have performed: Other studies utilizing similar laser therapy approaches have shown promise in treating brain tumors, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. 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).
3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
4. 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.
5. Preoperative Karnofsky score ≥ 70 (APPENDIX A).
6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.

   1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
   2. Platelets ≥ 100,000 cells/mm3
   3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
   4. 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.
   5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
   6. Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4
   7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
   8. Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
7. Patients must be able to understand and sign informed consent.

Exclusion Criteria:

1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7).
2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
3. Patients with a previous history of HIV infection.
4. Patients with uncontrolled hepatitis B or C infection.
5. Patients who have received any surgical resection for this tumor.

   a. Patients who have received an open biopsy for this disease are still eligible for participation.
6. Patients who have received chemotherapy or radiation for this disease.
7. Patients who are taking dofetilide (Section 4.10.1).
8. 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.
9. Patients not eligible to obtain MRI with and without contrast.
10. Recurrent HGG.
11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
12. Fever within 48 hours of surgery (Temperature\> 38.0°C).
13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
15. Pregnant women.
16. Patients must be willing to use contraception as described in Section 4.11.
17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
18. Prisoners.
19. Adults unable to consent.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Ashish Shah, MD — University of Miami
• Study coordinator: Ashish Shah, MD

Conditions High Grade Glioma; Unresectable High Grade Glioma