Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06428045 | RECRUITING | High Grade Glioma

STARLITE for Unresectable High-Grade Gliomas
Sponsor:

University of Miami

Information provided by (Responsible Party):

Ashish Shah

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.

Condition or disease

High Grade Glioma

Intervention/treatment

Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)

Abacavir

Lamivudine

Ritonavir

Temozolomide

Focal Radiotherapy

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
Actual Study Start Date : 2025-04-15
Estimated Primary Completion Date : 2029-04-30
Estimated Study Completion Date : 2030-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
STARLITE for Unresectable High-Grade Gliomas

Location Details

NCT06428045

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Miami, florida, United States, 33136