High Grade Glioma Clinical Trial
— STARLITEOfficial 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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | May 31, 2029 |
Est. primary completion date | May 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Medtronic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 6.0 (NCI CTCAE v6.0). | Up to 28 days | |
Primary | 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 6.0 (NCI CTCAE v6.0). | Up to 12 months | |
Secondary | Progression-Free Survival (PFS) | PFS is defined as percentage of participants without disease progression at time of study discontinuation. | Up to 24 months | |
Secondary | Overall Survival (OS) | Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation. | Up to 24 months |
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