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

NCT07145112 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: UCDCC321P30CA093373NCI-2025-069162352196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Up to 7 days post laser uinterstitial thermal therapy

Secondary Outcomes (1)

• Overall survival

  Up to 2 years following first dose of lomustine.

Study Arms (1)

Laser interstitial thermal therapy (LITT) + Lomustine (CCNU)

EXPERIMENTAL

Laser interstitial thermal therapy (LITT) + Lomustine (CCNU)

Procedure: Laser interstitial thermal therapy; Drug: Lomustine

Interventions

Laser interstitial thermal therapy PROCEDURE

MRI guided laser

Also known as: LITT

Laser interstitial thermal therapy (LITT) + Lomustine (CCNU)

Lomustine DRUG

Given orally (PO)

Also known as: CCNU, Gleostine

Laser interstitial thermal therapy (LITT) + Lomustine (CCNU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• a. 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95827, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Lomustine

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Orwa Aboud, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orwa Aboud, MD, PhD

CONTACT

916-734-3772; oaboud@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)