STARLITE for Unresectable High-Grade Gliomas

Launched by UNIVERSITY OF MIAMI · May 20, 2024

Keywords

ClinConnect Summary

The STARLITE clinical trial is studying a new treatment for patients with high-grade gliomas, which are aggressive brain tumors that cannot be surgically removed. The main goal of this study is to see how these tumors change after treatment and to find out what side effects the treatment may cause, both positive and negative. This trial is currently recruiting participants aged 18 and older who have been diagnosed with high-grade gliomas through MRI scans. To be eligible, participants need to have tumors that are difficult to remove safely and must meet certain health criteria, such as having a good level of physical functioning.

If you join this trial, you will receive a new treatment aimed at targeting your tumor. Throughout the study, doctors will closely monitor your health to understand how well the treatment works and to manage any side effects that may arise. It’s important to note that certain medical conditions and previous treatments may prevent you from participating, so a thorough screening will take place. This trial could help improve future treatments for high-grade gliomas, and your involvement could contribute to significant advancements in care for others facing similar challenges.

Gender

ALL

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.