LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Glioblastoma
• Intervention / Treatment: Procedure: Laser interstitial thermal therapy; Drug: Temozolomide

Detailed Description

This is an open-label, non-randomized Phase II study, planning to recruit about ten patients.

The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide.

The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: LITT with Early Application of Temozolomide; Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).

Procedure: Laser interstitial thermal therapy; Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.; Other Names: LITT; Drug: Temozolomide; 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.; Other Names: TMZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Progression (TTP)	TTP, defined as time from LITT to recorded tumor progression	12 months
Overall survival (OS)	OS, defined as time from diagnosis to death	18 months

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Dabiao Zhou, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Estimate): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: GBM; Glioblastoma; LITT; Laser Interstitial Thermal Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: KY2022-232-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No