NCT07145112

Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma

A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. All follow-up is based on standard of care for LITT and lomustine.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Laser interstitial thermal therapy	MRI guided laser
DRUG	Lomustine	Given orally (PO)

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2025-08-28
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study