LITT + Chemoradiation for Brain Tumor

Overseen By Teresa Allison

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Recurrent gliomas, Cerebral edema, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety of shortening treatment time for brain tumor patients using laser surgery (Laser Interstitial Thermal Therapy, LITT), radiation, and chemotherapy. Typically, a longer interval exists between surgery and the start of radiation with chemotherapy, but this study tests beginning treatment just 5 days post-surgery. The goal is to assess whether a quicker schedule can effectively target cancer cells. The trial seeks participants with a specific type of brain tumor called high-grade glioma, who have not undergone prior treatments and are suitable for laser surgery. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if 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?

A previous study found Laser Interstitial Thermal Therapy (LITT) to be mostly safe, with quick recovery times. Most side effects can be reversed, though some patients experienced brain swelling and bleeding inside the skull.

Research shows that the chemotherapy drug Temozolomide is generally safe when combined with radiation therapy. Patients have tolerated it well, even over several weeks of treatment.

The current trial is in an early stage, focusing on the safety of a shorter treatment schedule. This phase is crucial for understanding patient tolerance to the combined treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of LITT, radiation therapy, and Temozolomide for treating brain tumors because it introduces a new way to target and destroy tumor cells. Unlike traditional surgery, Laser Interstitial Thermal Therapy (LITT) uses a laser to precisely heat and kill tumor cells, minimizing damage to surrounding healthy tissue. This method, combined with radiation and chemotherapy using Temozolomide, aims to enhance the effectiveness of treatment by attacking the tumor on multiple fronts. This multi-modal approach could potentially improve outcomes and reduce side effects compared to current standard treatments like surgery, radiation alone, or chemotherapy alone.

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

Research has shown that Laser Interstitial Thermal Therapy (LITT) is safe and aids in quick recovery. It effectively treats hard-to-reach brain tumors. In this trial, participants will receive LITT followed by radiation therapy and Temozolomide. Radiation therapy, a well-established treatment for brain tumors, can effectively control their growth. Taking the chemotherapy pill Temozolomide alongside radiation has improved survival rates, particularly for certain types of brain cancer. This combination of treatments may work together to fight brain tumors more effectively. ^{3 4 5 6 7}

Who Is on the Research Team?

Jennifer Yu, MD, PhD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed high-grade gliomas who haven't had previous treatments. They must be in good enough health to undergo surgery, have a certain level of physical function (Karnofsky Performance status ≥ 60%), and have normal organ/marrow function. Women must not be pregnant and participants must agree to use contraception.

Inclusion Criteria

I can care for myself but may not be able to do active work.

I have not received any treatments for my current illness.

Subjects must have normal organ and marrow function as defined below: Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 10.0 g/dl (Use of transfusion or other intervention to achieve this hemoglobin level is acceptable), Blood urea nitrogen ≤ 30mg/dl and creatinine ≤ 1.7 mg/dl, Bilirubin ≤ 2.0 mg/dl, Aspartate aminotransferase/ Alanine aminotransferase (AST/ALT) ≤ 3x upper limit of normal, Electrocardiogram without evidence of acute cardiac ischemia, Prothrombin time/international normalized ratio (PT INR) <1.4, Women of childbearing potential and male participants must practice adequate contraception, For women of childbearing age, negative pregnancy test within 14 days prior to registration, Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I have had severe brain swelling before surgery.

I've had surgery complications affecting my daily activities or making me unfit for further cancer treatment.

My brain tumor has come back and is high grade.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo Laser Interstitial Thermal Therapy (LITT)

1 week

1 visit (in-person)

Chemoradiation

Radiation therapy with chemotherapy begins within 7 days after LITT

7 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LITT
• Radiation therapy
• Temozolomide

Trial Overview The study tests if it's safe to shorten brain tumor treatment by starting radiation and chemotherapy within 5 days after laser surgery (LITT), instead of the usual 21-28 days. The goal is to reduce total treatment time from about 10 weeks to just 7 weeks, potentially improving cancer cell eradication.

How Is the Trial Designed?

Group I: LITT with Radiation and Temozolomide Experimental Treatment 3 Interventions

Laser interstitial thermal therapy (LITT) followed by Radiation therapy, three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT), 60 Gy/30 fractions. Radiation given with chemotherapy Temozolomide

LITT is already approved in United States for the following indications:

Approved in United States as Laser Interstitial Thermal Therapy for:

• Primary brain tumors
• Metastatic brain tumors
• Radiation necrosis
• Epilepsy

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

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

Outcomes in Patients Treated with Laser Interstitial Thermal ... The results of this analysis indicate that LITT is a well‐tolerated procedure enabling some patients to discontinue steroids that may be effective for ...

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

Effectiveness of MR-guided LITT Therapy in Irresectable ... LITT has been shown to carry limited risk of post-operative complications, mostly reversible, and has been associated with fast recovery post-treatment. The ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7897607/

Laser interstitial thermotherapy (LITT) for the treatment of ... LITT is emerging as a safe, reliable, minimally invasive clinical approach, particularly for deep seated, focal malignant brain tumors and radiation necrosis.

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. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11171930/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028377024000754

Complications following laser interstitial thermal therapy Though generally safe, laser interstitial thermal therapy (LITT) can cause adverse effects. · Cerebral edema, intracranial hemorrhage, and focal neurologic ...