STARLITE for Unresectable High-Grade Gliomas
ConditionHigh Grade Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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
Qualifiers
Age ≥ 18 years.
Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.
Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
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.
Disqualifiers
Patients with human leukocyte antigen (HLA) HLA-B*5701 hypersensitivity (Section 10.1.6.7).
Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
Patients with a previous history of HIV infection.
Patients with uncontrolled hepatitis B or C infection.
Trial design
Treatments tested in this trial
- Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
- Abacavir
- Lamivudine
- Ritonavir
- Temozolomide
- Focal Radiotherapy
Treatment groups
24 Participants
are divided into 2 treatment groupsLocations
1University of Miami33136, MiamiFlorida, United States
Sponsors and collaborators
University of Miami
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov