STARLITE for Unresectable High-Grade Gliomas (NCT06428045) | Clinical Trial Compass
RecruitingPhase 1
STARLITE for Unresectable High-Grade Gliomas
United States24 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Preoperative Karnofsky score ≥ 70 (APPENDIX A).
. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Dose-Limiting Toxicity
Timeframe: Up to 28 days
2
Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events
. 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.
. Patients who have received any surgical resection for this tumor.
. Patients who have received chemotherapy or radiation for this disease.
. Patients who are taking dofetilide (Section 4.10.1).
. 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.