Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas

NCT02970448 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: CASE4316
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Grade Glioma

Keywords

LITT; Brain Tumor; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Study safety as determined by the number of patients who experience pre-specified adverse events

  pre-specified adverse events include: Wound dehiscence, grade 3 (CTCAE v4.0), Grade 3 Seizures (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications, Cerebral edema, grade 4 (CTCAE v4.0), Failure to complete of 60 Gy radiation

  Up to 12 weeks after LITT therapy

Secondary Outcomes (1)

• Number of patients with adjustments to radiation plan to account for post-LITT tissue distortion

  Up to 12 weeks after LITT therapy

Study Arms (1)

LITT with Radiation and Temozolomide

EXPERIMENTAL

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

Procedure: LITT; Radiation: Radiation therapy; Drug: Temozolomide

Interventions

LITT PROCEDURE

MRI-guided laser interstitial thermal therapy uses a gas cooled side-firing (directional) laser and a variety of procedure specific tools to thermally ablate target tissue in-situ.

Also known as: Laser interstitial thermal therapy

LITT with Radiation and Temozolomide

Radiation therapy RADIATION

One treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. All portals shall be treated during each treatment session. Doses are specified such that at least 95% of the planning target volume (PTV) shall receive 100% of the prescribed dose.

Also known as: 3D-Conformal radiation therapy (RT), Intensity Modulated RT

LITT with Radiation and Temozolomide

Temozolomide DRUG

Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days

LITT with Radiation and Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have suspected high grade glioma by MRI
• Subjects must have received no prior therapies for this disease.
• Patients must be considered appropriate candidates for LITT.
• Karnofsky Performance status ≥ 60%
• Subjects must have normal organ and marrow function as defined below. Measures of function must be within 14 days prior to registration.
• 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.

You may not qualify if:

• Participants not eligible to obtain MRI with and without contrast
• Recurrent High grade gliomas (HGG)
• Cerebral edema, grade 3 or greater prior to surgery
• Post-operative complications including significant neurological decline or hemorrhage that causes a drop in KPS to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician
• Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician.
• Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration of completion of protocol therapy
• Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
• Participants receiving other investigational agents.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Computer-Assisted; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Yu, MD, PhD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: August 24, 2017
• Primary Completion: November 10, 2023
• Study Completion: October 25, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)