Laser Therapy or Surgery for Recurrent Brain Cancer

Overseen By Subha Perni, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hematologic malignancies, Psychiatric illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage brain cancer that has returned after initial treatment with focused radiation (stereotactic radiosurgery, or SRS). It will test two approaches: Laser Interstitial Thermal Therapy (LITT), which uses heat to target cancer cells, and traditional surgery. Participants will be divided into groups to receive either close monitoring or additional SRS treatments. Suitable candidates for this trial include those with a solid tumor brain metastasis previously treated with SRS at least three months ago, now showing signs of progression. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in brain cancer management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown promising safety results for Laser Interstitial Thermal Therapy (LITT). Research indicates that LITT can safely and effectively shrink tumors, with success in about 85% to 95% of cases, meaning most patients did not experience serious side effects.

Surgery has long been used to treat brain tumors. Studies have found that surgery for recurrent brain tumors is generally well-tolerated, with complication rates low and only about 7% to 11% of patients experiencing long-term issues. This suggests that surgery is a reliable option with a good safety record.

Both treatments are considered safe based on past studies. For concerns, it is best to consult a doctor to determine which option might be suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for recurrent brain cancer because they offer innovative approaches that could improve outcomes. Laser Interstitial Thermal Therapy (LITT) is unique as it uses precise, targeted heat to destroy cancer cells, potentially leading to less damage to surrounding healthy tissue compared to traditional surgery. This could mean a quicker recovery and fewer side effects for patients. Additionally, the trial is exploring how close surveillance can be effectively integrated with LITT or surgery, aiming to optimize patient care by tailoring treatment intensity to individual needs. This personalized approach could revolutionize how recurrent brain cancer is managed, making it less invasive and more adaptive to each patient's condition.

What evidence suggests that this trial's treatments could be effective for recurrent brain cancer?

Research has shown that Laser Interstitial Thermal Therapy (LITT), a treatment under study in this trial, offers a promising option for brain tumors, even when they recur. Studies have found that LITT effectively controls the tumor in about 87.4% of cases after six months for certain conditions. It also helps patients maintain their quality of life post-treatment. For recurrent brain tumors, using LITT alongside other treatments has resulted in an average survival time of 12.8 months. This suggests that LITT is not only safe but also potentially effective for managing recurrent brain cancer. Participants in this trial may receive either LITT or surgery, depending on their treatment arm assignment. ^{3 5 6 7 8}

Who Is on the Research Team?

Subha Perni, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a solid tumor brain metastasis previously treated with radiosurgery at least 3 months ago. Participants must be MRI-compatible, have measurable disease, and no leptomeningeal disease. They should be able to follow the study plan and sign consent. Those with other cancers not affecting the study can join. Excluded are pregnant women, patients with psychiatric issues affecting compliance, hematologic brain metastases, or those unfit for reirradiation.

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study

My brain tumor may be growing despite having had targeted radiation therapy over 3 months ago.

Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review

Exclusion Criteria

Patients with psychiatric illness/social situations that would limit compliance with study requirements

I have brain metastases from blood cancer.

I am not pregnant and cannot become pregnant due to menopause, surgery, or other medical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Laser Interstitial Thermal Therapy (LITT) or surgery followed by SRS2 or close surveillance

8-12 weeks

Follow-up

Participants are monitored for safety, adverse events, and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Laser Interstitial Thermal Therapy (LITT)
• Surgery

Trial Overview The LaSAR BeaM trial is testing whether Laser Interstitial Thermal Therapy (LITT) followed by adjuvant reirradiation improves outcomes in recurrent brain metastases compared to surgery plus reirradiation after initial stereotactic radiosurgery treatment.

How Is the Trial Designed?

Group I: Ineligible for surgery or LITT-SRS2 Experimental Treatment 2 Interventions

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Group II: Eligible for surgery or LITT-Surveillance Experimental Treatment 2 Interventions

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Group III: Eligible for surgery or LITT-SRS2 Experimental Treatment 2 Interventions

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9122789/

Efficacy of laser interstitial thermal therapy (LITT) for newly ... Laser ablation has demonstrated safety as a surgical approach to treating primary brain tumors. The LAANTERN prospective multicenter registry (NCT02392078) data ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05318612

NCT05318612 | Effectiveness of MR-guided LITT Therapy ... The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028377025000025

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 ...

4. thejns.org thejns.org/focus/view/journals/neurosurg-focus/57/5/article-pE4.xml

An analysis of functional outcomes following laser interstitial ... The majority of patients undergoing LITT for recurrent HGG had a favorable functional outcome at the initial follow-up visit. The treated tumor volume was ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2021.1889696

The efficacy of laser interstitial thermal therapy for brain ... Our study showed that LITT provided more satisfactory local control efficacy on RN than BM recurrence with higher LC-6 (87.4% vs. 67.9%, p = 0.009) and LC-12 ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6975949/

Outcomes in Patients Treated with Laser Interstitial Thermal ... Laser interstitial thermal therapy (LITT) is a novel therapy for addressing radiation necrosis and local tumor progression.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846720302857

Survival outcomes in patients with recurrent glioblastoma ... Laser interstitial thermal therapy provides an effective treatment with low morbidity for selected patients harboring recurrent glioblastoma.

8. mdpi.com mdpi.com/2072-6694/16/11/2131

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 ...