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

ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Laser interstitial thermal therapy

    Procedure/Surgery

    MRI guided laser

  • Lomustine

    Drug

    Given orally (PO)

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Laser interstitial thermal therapy (LITT) + Lomustine (CCNU)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 6 weeks after first dose of lomustine
2

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).

Time frame
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.

Time frame
Up to 2 years following first dose of lomustine.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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