GlioblastomaPhase 1NCT07145112
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
A Phase 1 study testing Laser interstitial thermal therapy and Lomustine in people with Glioblastoma, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Laser interstitial thermal therapy and Lomustine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- The following listed agents/interventions must have been discontinued for their respective time period prior to enrollment:
Show all 21Show fewer
- Four weeks from cytotoxic agents (3 weeks from procarbazine, 3 weeks from vincristine, and 4 weeks from temozolomide);
- Four weeks or 5 drug half-lives (whichever is shorter) from any investigational agent; two weeks or 5 drug half-lives (whichever is shorter) from non-cytotoxic agents (e.g. Accutane, thalidomide);
- Twelve weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progressive disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field;
- Patients must have the following laboratory parameters ≤ 14 days prior to registration:
- adequate bone marrow function defined by: i. white blood cells (WBC) ≥ 3 × 109/L , ii. absolute neutrophil count (ANC) ≥ 1.5 × 109/L , iii. platelet count of ≥ 100 × 109/L , and iv. hemoglobin ≥ 9 gm/dL b. adequate liver function defined by i. alanine transaminase (ALT, SGPT) and aspartate transaminase (AST/SGOT) < 3× institutional upper limit of normal (ULN), ii. alkaline phosphatase < 2× ULN, and iii. bilirubin < 1.5 mg/dL c. adequate renal function defined by calculated creatinine clearance ≥ 60 mL/min (see Appendix)
- Karnofsky performance status (KPS) ≥ 50 (see Appendix).
- Individuals of childbearing potential or those with partners of childbearing potential must agree to use adequate methods of contraception for the duration of study participation (including dosing interruptions) and for up to 3.5 months after the last study treatment; or be surgically sterilized.
- Patients on the following medications are allowed:
- Anticoagulants: Patients on stable dose anticoagulants (e.g. warfarin in-range international normalized ratio [INR], low molecular-weight heparin)
- Patients are allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox, ibuprofen and other NSAIDS.
- Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy for glioblastoma while enrolled in the study.
- Able to swallow oral medication.
- Patients ≥18 years of age at time of consent.
- Ability to understand and willingness to sign an informed consent form (ICF).
- Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements, including periodic blood sampling and study related assessments
Who cannot join
- Patients who are not surgical candidates for stereotactic biopsy or laser ablation.
- Prior treatment with nitrosourea agents (e.g. lomustine [CCNU], carmustine [BCNU], nimustine [ACNU]).
- Prior treatment with polifeprosan 20 with carmustine wafer.
- Prior treatment with bevacizumab.
- Patients who have received any investigational agents ≤ 4 weeks or 5 drug half-lives (whichever is shorter) prior to commencing study treatment.
- Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions: (1) presence of hemosiderin, (2) resolving hemorrhagic changes related to surgery, or (3) presence of punctate hemorrhage in the tumor.
Show all 15Show fewer
- History of intracerebral abscess within 6 months prior to Day 1.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to Day 1, or anticipation of the need for a major surgical procedure during the course of the study.
- Serious non-healing wound, ulcer, or bone fracture.
- Pregnancy (positive pregnancy test) or lactation.
- Known hypersensitivity to any component of lomustine (CCNU).
- Uncontrolled intercurrent illness or unstable systemic disease, including, but not limited to, ongoing or active infection, uncontrolled hypertension, or serious cardiac arrhythmia requiring medication that would interfere with participant safety or limit compliance with the study requirements.
- Unable to undergo an MRI with contrast.
- Known allergy to nitrosoureas (e.g., lomustine, carmustine, nimustine).
- Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95827
Orwa Aboud, MD, PhD, 916-734-3772, oaboud@health.ucdavis.edu
Orwa Aboud, MD, PhD
About this study
Official title: A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults
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.
Read the 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
- Being tested
- Laser interstitial thermal therapy, Lomustine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser interstitial thermal therapyProcedure or surgery
Also called LITT
MRI guided laser
LomustineDrug
Also called CCNU, Gleostine
Given orally (PO)
| Study group | Role | What they receive |
|---|---|---|
| Laser interstitial thermal therapy (LITT) + Lomustine (CCNU) | Experimental | Laser interstitial thermal therapy (LITT) + Lomustine (CCNU) Receives: Procedure: Laser interstitial thermal therapy; Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the combination of Laser Interstitial Thermal Therapy (LITT) and lomustine in patients with recurrent glioblastoma.
Number of treatment related adverse events, grade 3 and 4 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Up to 6 weeks after first dose of lomustine
Tolerability of the combination of Laser Interstitial Thermal Therapy (LITT) and lomustine in patients with recurrent glioblastoma.
Percentage of participants completing LITT and receiving 1 dose of lomustine within the proposed timeframe (e.g., 7 days).
Measured: Up to 7 days post laser uinterstitial thermal therapy
Secondary outcomes (1)
Overall survival
Median time of presentation to date of death or censored at last follow-up date.
Measured: Up to 2 years following first dose of lomustine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Orwa Aboud, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145112
- Sponsor's protocol ID
- UCDCC321
- Other IDs
- P30CA093373, NCI-2025-06916, 2352196
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults
- ClinicalTrials.gov ID
- NCT07145112
- Acronym / sponsor ID
- UCDCC321
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser interstitial thermal therapy (LITT) + Lomustine (CCNU) | Experimental | Procedure: Laser interstitial thermal therapy, Drug: LomustineLaser interstitial thermal therapy (LITT) + Lomustine (CCNU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (15 listed)
- Patients who are not surgical candidates for stereotactic biopsy or laser ablation.
- Prior treatment with nitrosourea agents (e.g. lomustine [CCNU], carmustine [BCNU], nimustine [ACNU]).
- Prior treatment with polifeprosan 20 with carmustine wafer.
- Prior treatment with bevacizumab.
- Patients who have received any investigational agents ≤ 4 weeks or 5 drug half-lives (whichever is shorter) prior to commencing study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser interstitial thermal therapyAlso: LITTMRI guided laser | Procedure or surgery | Laser interstitial thermal therapy (LITT) + Lomustine (CCNU) |
| LomustineAlso: CCNU, GleostineGiven orally (PO) | Drug | Laser interstitial thermal therapy (LITT) + Lomustine (CCNU) |
Primary outcome
Safety of the combination of Laser Interstitial Thermal Therapy (LITT) and lomustine in patients with recurrent glioblastoma.
Time frame: Up to 6 weeks after first dose of lomustine
Number of treatment related adverse events, grade 3 and 4 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Tolerability of the combination of Laser Interstitial Thermal Therapy (LITT) and lomustine in patients with recurrent glioblastoma.
Time frame: Up to 7 days post laser uinterstitial thermal therapy
Percentage of participants completing LITT and receiving 1 dose of lomustine within the proposed timeframe (e.g., 7 days).
1 secondary outcome
Overall survival
Time frame: Up to 2 years following first dose of lomustine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Glioblastoma
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingPhase 2
Tamoxifen Versus Etoposide After First Recurrence in GBM Patients
Glioblastoma Multiforme
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Orwa Aboud, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laser interstitial thermal therapy and Lomustine in people with Glioblastoma, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the combination of Laser Interstitial Thermal Therapy (LITT) and lomustine in patients with recurrent glioblastoma. (time frame: Up to 6 weeks after first dose of lomustine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.