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)
University of California, San Francisco
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.
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 progre…
Eligibility
- Age range
- 2–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have recurrent or progressive pediatric LGG who have received at least one prior treatment. Prior treatment may include surgery alone and/or systemic therapy. * Participants must have histologically confirmed LGG that is recurrent or progressive after prior treatment and determined to be a candidate for LITT by central review. All patients will undergo central review prior to LITT. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria. * Tumor size: up to 5 cm in largest dimension not including any c…
Interventions
- DeviceLaser Interstitial Thermal Therapy (LITT)
Perform ablation using LITT
- ProcedureMagnetic resonance imaging (MRI)
Undergo single imaging procedure
- OtherQuestionnaires
Participants will complete questionnaires
Location
- University of California, San FranciscoSan Francisco, California