NCT06428045 STARLITE for Unresectable High-Grade Gliomas
| NCT ID | NCT06428045 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Miami |
| Condition | High Grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-04-15 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Ashish Shah, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06428045 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High Grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06428045 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06428045 currently recruiting?
Yes, NCT06428045 is actively recruiting participants. Contact the research team at ashah@med.miami.edu for enrollment information.
Where is the NCT06428045 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06428045 clinical trial?
NCT06428045 is sponsored by University of Miami. The principal investigator is Ashish Shah, MD at University of Miami. The trial plans to enroll 24 participants.