Clinical trial NCT06428045: STARLITE for Unresectable High-Grade Gliomas
Official title: Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: High Grade Glioma
Keywords: Unresectable High Grade Glioma
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2024-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 dose escalation/de-escalation and dose expansion design.
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Number of Participants Experiencing Dose-Limiting Toxicity
timeFrame: Up to 28 days
measure: Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ashish Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Macarena De La Fuente, MD
role: PRINCIPAL_INVESTIGATOR
References: