LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Phase 1

Active, not recruiting

• Conditions: Recurrent Glioblastoma
• Interventions: Procedure: Laser interstitial thermal therapy; Drug: Temozolomide

• Registration Number: NCT05663125
• Lead Sponsor: Beijing Tiantan Hospital

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.

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 Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LITT with Early Application of Temozolomide	Laser interstitial thermal therapy	Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).
LITT with Early Application of Temozolomide	Temozolomide	Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).

Primary Outcome Measures

Name	Time	Method
Adverse Events	From Day 1 throughout the study until 3 months	To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	12 months	TTP, defined as time from LITT to recorded tumor progression
Overall survival (OS)	18 months	OS, defined as time from diagnosis to death

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China