RECRUITING

STARLITE for Unresectable High-Grade Gliomas

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Conditions

High Grade GliomaUnresectable High Grade Glioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

Quick Facts

Study Start:2025-07-01
Study Completion:2030-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06428045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years.
  2. 2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.
  3. 3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
  4. 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. 5. Preoperative Karnofsky score ≥ 70 (APPENDIX A).
  6. 6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
  7. 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
  8. 2. Platelets ≥ 100,000 cells/mm3
  9. 3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
  10. 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.
  11. 5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
  12. 6. Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4
  13. 7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
  14. 8. Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
  15. 7. Patients must be able to understand and sign informed consent.
  1. 1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7).
  2. 2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
  3. 3. Patients with a previous history of HIV infection.
  4. 4. Patients with uncontrolled hepatitis B or C infection.
  5. 5. Patients who have received any surgical resection for this tumor.
  6. 6. Patients who have received chemotherapy or radiation for this disease.
  7. 7. Patients who are taking dofetilide (Section 4.10.1).
  8. 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. 9. Patients not eligible to obtain MRI with and without contrast.
  10. 10. Recurrent HGG.
  11. 11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
  12. 12. Fever within 48 hours of surgery (Temperature\> 38.0°C).
  13. 13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
  14. 14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
  15. 15. Pregnant women.
  16. 16. Patients must be willing to use contraception as described in Section 4.11.
  17. 17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
  18. 18. Prisoners.
  19. 19. Adults unable to consent.

Contacts and Locations

Study Contact

Ashish Shah, MD
CONTACT
(305) 243-6946
ashah@med.miami.edu
Macarena De La Fuente, MD
CONTACT
(305) 243-2858
MDelaFuente@med.miami.edu

Principal Investigator

Ashish Shah, MD
PRINCIPAL_INVESTIGATOR
University of Miami
Macarena De La Fuente, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Ashish Shah, MD, PRINCIPAL_INVESTIGATOR, University of Miami
  • Macarena De La Fuente, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2030-07-31

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2030-07-31

Terms related to this study

Keywords Provided by Researchers

  • Unresectable High Grade Glioma

Additional Relevant MeSH Terms

  • High Grade Glioma