Actively Recruiting

Phase Not Applicable
Age: 2Years - 25Years
All Genders
NCT07506239

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

Led by University of California, San Francisco · Updated on 2026-04-01

40

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

P

Pacific Pediatric Neuro-Oncology Consortium

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have recurrent or progressive pediatric low-grade glioma (LGG) confirmed by histology and be candidates for LITT after prior treatment including surgery and/or systemic therapy.
  • Tumor size up to 5 cm in largest dimension, excluding cystic components; larger tumors require discussion.
  • Tumors must be located in brain or central nervous system areas accessible and safe for LITT as determined by central review.
  • Suprasellar gliomas not arising from the optic pathway are eligible.
  • Multifocal or metastatic LGGs are eligible if growing lesions are suitable for LITT.
  • Exophytic brainstem lesions may be eligible.
  • Stable leptomeningeal disease with a separate growing lesion suitable for LITT is allowed.
  • Prior LITT allowed only if new lesion not previously treated or if progression occurred after 15 months.
  • Participants must have recovered from toxic effects of prior therapies and be eligible for surgery.
  • Last bevacizumab dose must be more than 21 days before registration.
  • Last chemotherapy dose > 3 weeks prior (6 weeks for nitrosoureas or mitomycin C).
  • At least 7 days since last biologic or small molecule therapy, accounting for known adverse event timing.
  • Last fraction of local irradiation or focal radiosurgery at least 12 weeks before registration.
  • Last fraction of craniospinal or total body irradiation at least 12 weeks before registration.
  • Age between 2 and 25 years.
  • Performance score of Karnofsky ≥ 50 for >16 years old or Lansky ≥ 50 for ≤16 years old; wheelchair-bound participants considered ambulatory.
  • Stable or decreasing dexamethasone dose for at least 1 week prior.
  • Surgically eligible per institutional standards.
  • Must co-enroll in Pediatric Neuro-oncology Consortium COMP if available.
  • Informed consent and assent obtained as appropriate.
Not Eligible

You will not qualify if you...

  • Contraindications to LITT including optic pathway gliomas, spinal tumors, infiltrative brainstem lesions, or any lesion/location deemed unsafe by central review.
  • Presence of uncontrolled leptomeningeal or extracranial disease.
  • Untreated obstructive hydrocephalus or mass effect causing >10 mm midline shift.
  • Symptomatic intratumoral hemorrhage grades 3 and 4; grade 2 requires discussion.
  • Receiving other investigational agents.
  • Uncontrolled intercurrent illness including active infections.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

P

PNOC Operations Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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