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

13 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks. To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery. Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.

Research Team

Jennifer Yu, MD, PhD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+