Fig 1.
SPIRIT schedule of enrollment, interventions, and assessments for the STARLITE clinical trial.
Abbreviations: ART, antiretroviral therapy; GBM, glioblastoma; LITT: laser interstitial thermal therapy; MTD, maximum tolerated dose; POD: postoperative day; RP2D, recommended phase 2 dose; TMZ: temozolomide.*Screening assessments are to be conducted up to 7 days before initiating the study, unless otherwise specified. 1 Patients will be evaluated by the neurosurgical team prior to surgery and will have either a suspected diagnosis of a GBM or a histologically confirmed GBM at the time of enrollment. If frozen section diagnosis is equivocal or non-diagnostic of glioma, the patient(s) may continue to receive LITT at the surgeon’s discretion and will be deferred for further study participation until the histological review is complete. 2 Single-arm study. 3 In part 1, the ritonavir dose will be dose escalated/de-escalated using at most four dose levels of ritonavir to determine the potential MTD (or RP2D, if the MTD is not attained). In part 2, ritonavir will be administered at the MTD (or RP2D, if the MTD is not attained) determined from part 1 of the study. 4 Patients may receive ART beyond their participation in this study at the discretion of their treating physician. ART may begin later if the participant is considered unable to begin treatment due to their postoperative condition, i.e., inability to swallow medications. 5 Adjuvant therapy consisting of radiotherapy and TMZ will be administered to all patients starting on POD14 ± 7 days, provided patients have sufficiently recovered from surgery. 6 Following completion of radiotherapy and the 6-week (42-day) regimen of 75 mg/m² TMZ, patients will have a 4-week (±2 week) rest period before starting adjuvant TMZ treatment, which will be administered for six 28-day cycles (168 days total) as follows: Cycle 1 at a dose of 150 mg/m² one time per day on days 1–5 of a 28-day cycle and Cycles 2–6 at a dose of 200 mg/m² one time per day on days 1–5 of a 28-day cycle. Please note that dose and frequency of TMZ administration may be altered at the discretion of the treating neuro-oncologist. 7 Radiographic assessments will occur at POD180, POD365, and/or at the timing of the best radiographic response.
Table 1.
Overview of inclusion and exclusion criteria.
Table 2.
STARLITE part 1 dose regimen.
Fig 2.
Graphic showing synergy of LITT and ART being evaluated in STARLITE clinical trial.
Created in BioRender.com.
Fig 3.
Timeline of STARLITE trial including Screening, Treatment, and Safety Follow-up Periods.
Abbreviations: ART, anti-retroviral therapy; LITT, laser interstitial thermal therapy. Created in BioRender.com.