NCT07506239

Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma

PNOC042: A Phase 2, Multi-institutional Trial, Evaluating the Efficacy of Laser Interstitial Thermal Therapy (LITT) in Children, Adolescents and Young Adults With Recurrent or Progressive Low-grade Gliomas (LGG)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of Laser Interstitial Thermal Therapy (LITT) in treating recurrent or progressive, low-grade gliomas (LGG) in pediatric, adolescent and young adult patients.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the proportion of patients with recurrent or progressive LGGs who do not exhibit further disease progression at 15 months post-LITT. EXPLORATORY OBJECTIVES: I. To determine the safety and describe the toxicity of LITT in children and young adults with recurrent or progressive LGGs according to the NCI CTCAE v6.0. II. To estimate the duration of response (DOR) following LITT in children and young adults with recurrent or progressive LGGs. III. To estimate the objective response rate (ORR) following LITT in children and young adults with recurrent or progressive LGGs. IV. To estimate the time to next treatment following LITT in children and young adults with recurrent or progressive LGGs. V. To evaluate the potential effect of LITT on cystic tumors radiographically. VI. To evaluate the impact of the extent of ablation on DOR, ORR, and PFS VII. To evaluate the impact of seizure frequency following LITT by using Engel classification and the International League Against Epilepsy (ILAE) outcome scale at 3 months, 1- and 2- years. VIII. To evaluate the impact of ablation volume on the development of symptomatic post-ablation edema as indicated by the need to initiate treatment with Dexamethasone or bevacizumab for symptomatic edema within 60 days following the procedure. OUTLINE: Participants receive Laser Interstitial Thermal Therapy (LITT) and are followed for 24 months from the day of LITT. Participants will then be transitioned to the PNOC COMP protocol and followed until death or withdrawal from study.

Conditions

• Low-grade Glioma
• Recurrent Low Grade Glioma
• Low Grade Glioma of Brain
• Pediatric Cancer

Interventions

Type	Name	Description
DEVICE	Laser Interstitial Thermal Therapy (LITT)	Perform ablation using LITT
PROCEDURE	Magnetic resonance imaging (MRI)	Undergo single imaging procedure
OTHER	Questionnaires	Participants will complete questionnaires

Timeline

• Start date: 2026-03-25
• Primary completion: 2030-01-01
• Completion: 2031-01-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study