Actively Recruiting
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
Led by University of California, Davis · Updated on 2025-10-09
20
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed glioblastoma as defined by WHO 2021.
- Evidence of disease progression on imaging after prior therapy.
- Patients recovered from recent surgery for recurrent tumor.
- Prior standard radiation therapy for glioblastoma allowed.
- Recovery from effects of prior treatments.
- Discontinuation of prior cytotoxic, investigational, and radiotherapy treatments within specified timeframes.
- Adequate bone marrow, liver, and kidney function within 14 days before registration.
- Karnofsky performance status of 50 or higher.
- Use of effective contraception or surgical sterilization for those of childbearing potential.
- Allowed use of stable dose anticoagulants and certain antiplatelet or NSAID medications.
- Willingness to avoid other glioblastoma drug therapies during the study.
- Ability to swallow oral medications.
- At least 18 years old at consent.
- Ability to understand and sign informed consent.
- Willingness to follow study visit schedules and procedures including blood sampling.
You will not qualify if you...
- Not eligible for stereotactic biopsy or laser ablation surgery.
- Previous treatment with nitrosoureas such as lomustine.
- Prior treatment with carmustine wafers or bevacizumab.
- Use of investigational agents within 4 weeks or 5 half-lives before study.
- Recent brain hemorrhage except for certain minor or resolving cases.
- History of intracerebral abscess within 6 months.
- Major surgery or trauma within 28 days before Day 1 or planned major surgery during study.
- Serious non-healing wounds, ulcers, or bone fractures.
- Pregnancy or breastfeeding.
- Known allergy to lomustine or related drugs.
- Uncontrolled illness or unstable systemic disease that might affect safety or compliance.
- Unable to have MRI with contrast.
- Any condition that might interfere with safety or study compliance as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95827
Actively Recruiting
Research Team
O
Orwa Aboud, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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