RecruitingPhase 1NCT07145112

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


Sponsor

University of California, Davis

Enrollment

20 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of laser heat therapy (LITT — laser interstitial thermal therapy) and a chemotherapy drug called lomustine (CCNU) for people with recurrent glioblastoma (a brain tumor that has come back after initial treatment). The laser treatment destroys tumor tissue with heat, and the chemotherapy may improve effectiveness. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of glioblastoma that has returned or is growing after prior treatment - You have had prior standard radiation for glioblastoma - Your blood counts, liver, and kidney function meet required levels - Your general health and functional status are adequate (Karnofsky score of 50 or above) - You are able to swallow oral medication **You may NOT be eligible if...** - You are not a surgical candidate for laser ablation or biopsy - You have previously received a nitrosourea drug (such as lomustine, carmustine, or nimustine) - You have previously received bevacizumab (Avastin) - You had a recent major surgery within the past 4 weeks - You have evidence of significant active bleeding in the brain - You are pregnant or breastfeeding - You have a known allergy to lomustine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaser interstitial thermal therapy

MRI guided laser

DRUGLomustine

Given orally (PO)


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT07145112


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