Laser Interstitial Thermal Therapy + Lomustine

The LITT procedure is performed per standard of care under general anesthesia using a stereotactic neurosurgical approach where a laser catheter is precisely inserted into the tumor under MRI guidance. Real-time MRI thermometry is used to ensure controlled tumor ablation while minimizing damage to adjacent structures.

Patients typically undergo postoperative MRI to assess treatment response, and most can be discharged within 24-48 hours, facilitating early initiation of adjuvant therapy. Approximately 7 days following LITT, lomustine is administered per standard of care on Day 1 for a total of one cycle. Participants will be monitored for serious and non-serious adverse events (AE) starting from initiation of LITT per institutional practices.

This is a phase 1 study evaluating the safety and feasibility of laser interstitial thermal therapy (LITT) followed by lomustine (CCNU) for recurrent glioblastoma in adults. The primary aim is to evaluate the safety of the combination of LITT plus lomustine based on the assessment of treatment-related adverse events and the feasibility of completing LITT + lomustine in the proposed timeframe.

The secondary aim is to assess overall survival for up to 2 years after the first dose of lomustine.

Registro actualizado en ClinicalTrials.gov →

• Histologically confirmed World Health Organization (WHO) 2021 defined glioblastoma. A pathology report constitutes adequate documentation of histology for study inclusion.
• Radiographic demonstration of disease progression following prior therapy.
• Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the patient has recovered from surgery. Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study.
• Prior standard radiation for glioblastoma (short course 40 Gy, standard 60 Gy, and proton therapy are allowed).
• Patients must have recovered from the effects of prior therapy.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.