40 Participants NeededMy employer runs this trial

Laser Therapy for Brain Tumor

PO
Overseen ByPNOC Operations Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Laser Interstitial Thermal Therapy (LITT) to evaluate its effectiveness for children, teens, and young adults with recurring or worsening low-grade gliomas, a type of brain tumor. The goal is to determine if LITT can effectively treat these tumors when previous treatments have failed. Individuals with recurrent brain tumors that LITT can safely access, and who have already tried at least one other treatment, might be suitable candidates. Participants will undergo close monitoring and must provide health information during and after the treatment. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have recovered from any recent chemotherapy or targeted therapy, and there are specific waiting periods after certain treatments before you can join the study.

What prior data suggests that Laser Interstitial Thermal Therapy (LITT) is safe for treating brain tumors?

Research has shown that Laser Interstitial Thermal Therapy (LITT) is generally safe for treating brain tumors. A review of 45 studies found that about 30% of patients experienced side effects, with swelling, weakness, and seizures being the most common, though usually temporary. The data also indicate that LITT effectively targets tumors, achieving success rates as high as 94.8% in removing tumor tissue. While complications can occur, patients often tolerate LITT well. It is important to consult a doctor to understand how these findings apply to individual cases.12345

Why are researchers excited about this trial?

Laser Interstitial Thermal Therapy (LITT) is unique because it uses precise laser technology to target and destroy brain tumor tissues while sparing surrounding healthy brain tissue. Unlike traditional surgery, which can be more invasive, LITT is a minimally invasive procedure, potentially leading to faster recovery times and fewer complications. Researchers are excited about LITT because it offers a more targeted approach, which could improve outcomes and quality of life for patients with brain tumors.

What evidence suggests that Laser Interstitial Thermal Therapy (LITT) might be an effective treatment for low-grade gliomas?

Studies have shown that Laser Interstitial Thermal Therapy (LITT), which participants in this trial will receive, can effectively treat brain tumors. Research indicates that LITT can extend survival for patients with hard-to-reach brain tumors, outperforming mere tumor sampling. One study found that LITT increased the average survival time by more than six months. Another study reported that LITT successfully removed 94.8% of tumors in certain types of brain cancer. These results suggest that LITT can be a strong option for managing recurrent or persistent brain tumors.14678

Who Is on the Research Team?

SM

Sabine Mueller, MD, PhD

Principal Investigator

University of California, San Francisco

MS

Margaret Shatara

Principal Investigator

Children's Minnesota

Are You a Good Fit for This Trial?

This trial is for children, teens, and young adults (ages 2–25) with low-grade brain tumors that have come back or are growing after at least one prior treatment. Tumors must be in a location safe for laser therapy. Patients need to be healthy enough for surgery and recovered from previous treatments.

Inclusion Criteria

My tumor is 5 cm or smaller, not counting any cysts.
I finished my last biologic or small molecule therapy at least 7 days ago.
My suprasellar glioma did not start in the optic pathway.
See 18 more

Exclusion Criteria

I do not have tumors in areas where LITT is unsafe, like the optic pathway or spinal cord.
I do not have uncontrolled brain or body disease, severe brain swelling, or serious tumor bleeding.
Participants who are receiving any other investigational agents.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Laser Interstitial Thermal Therapy (LITT) and are monitored for immediate complications and recovery progress

Immediate post-procedure
Safety follow-up visits at 14 and 28 days post-procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging and questionnaires at 3 months, 1 year, and 2 years post-treatment

24 months
Regular follow-up visits and imaging

Long-term follow-up

Participants are transitioned to the PNOC COMP protocol and followed until death or withdrawal from the study

What Are the Treatments Tested in This Trial?

Interventions

  • Laser Interstitial Thermal Therapy (LITT)

Trial Overview

The study is testing Laser Interstitial Thermal Therapy (LITT), a minimally invasive procedure using heat to destroy tumor tissue, in young people with recurring or progressing low-grade gliomas. MRI scans and questionnaires will also be used to monitor outcomes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experiment: Laser Interstitial Thermal Therapy (LITT)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Pacific Pediatric Neuro-Oncology Consortium

Collaborator

Trials
16
Recruited
840+

Citations

Outcomes in Patients Treated with Laser Interstitial Thermal ...

LITT provides a novel therapeutic opportunity for addressing both radiation necrosis and local tumor progression. Following focal high‐dose radiation, radiation ...

An analysis of functional outcomes following laser interstitial ...

Studies have shown that LITT is effective and confers a survival benefit compared with biopsy alone in deep-seated lesions and comparable survival to the ...

Synergistic effects of laser interstitial thermal therapy (LITT) ...

LITT and immunotherapy show promise as a synergistic approach for recurrent brain tumors. · Combined therapy resulted in a median survival of 12.8 months for ...

Advanced Brain Cancer Survival Rates Double with LITT

Results showed that LITT improved median survival by 6.6 months, more than doubling it. While none of the patients who received conventional ...

Efficacy of laser interstitial thermal therapy (LITT) for newly ...

The efficacy of LITT for the management of primary and metastatic brain tumors has not been evaluated in randomized clinical trials because of challenges with ...

Safety and Efficacy of Laser Interstitial Thermal Therapy as ...

The pooled data suggest LITT may be a safe primary management option with tumor ablation rates of 94.8% and 84.6% in IDH-wildtype glioblastoma ...

Laser Interstitial Thermal Therapy Brain Tumor Evidence ...

2 The summaries on the following pages address outcomes such as length of hospital stay, extent of tumor ablation, adverse events, and other procedural details ...

Laser Interstitial Thermal Therapy (LITT) in Brain Tumors

In addition, LITT is generally safe. A recent meta-analysis of 45 studies found that the overall incidence of LITT-related adverse events is 30%; however, most ...