LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

NCT05663125 | Unknown Phase 1

• 1 other identifier: KY2022-232-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.

Conditions

Recurrent Glioblastoma

Keywords

GBM; Glioblastoma; LITT; Laser Interstitial Thermal Therapy

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.

  From Day 1 throughout the study until 3 months

Secondary Outcomes (2)

• Time to Progression (TTP)

  12 months

• Overall survival (OS)

  18 months

Study Arms (1)

LITT with Early Application of Temozolomide

EXPERIMENTAL

Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).

Procedure: Laser interstitial thermal therapy; Drug: Temozolomide

Interventions

Laser interstitial thermal therapy PROCEDURE

Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.

Also known as: LITT

LITT with Early Application of Temozolomide

Temozolomide DRUG

Temozolomide will be administered continuously from the 1st to the 21st day after LITT surgery. The oral dose of temozolomide is 75 mg/m2. And then, it will be given at a routine dose from the second month after surgery.

Also known as: TMZ

LITT with Early Application of Temozolomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Imaging (PET-MRI) indicates tumor progression or recurrence
• Patient ≥18 years old
• The tumor was the first-time recurrence
• The pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4)
• MRI indicated a single tumor or multiple tumors with visual enhancement =\<3cm
• Maximum tumor diameter: single tumor =\<3cm; Multiple tumors, targeted lesion =\<3cm
• Single tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamus
• KPS score \>=60 within 30 days before treatment
• No serious liver or kidney dysfunction
• Patients must be able to understand how to sign the informed consent document

You may not qualify if:

• The tumor crossed the midline or involved bilateral cerebral hemispheres
• Inability to perform MRI examination or intolerance to MRI contrast agent
• There is an active infection of the patient
• The patient had abnormal coagulation function
• Imaging before treatment indicated signs of cerebral hernia or midline displacement \> 1.0cm
• The patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrence
• Patients who have participated in clinical trials of any other drug or medical device within three months of the screening.
• KPS score =\<50 points

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dabiao Zhou, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 23, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2024
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)