LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Recurrent Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05663125
• Other study ID #: KY2022-232-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2022
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrence
• Recurrent Glioblastoma

Intervention

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.

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Progression (TTP)	TTP, defined as time from LITT to recorded tumor progression	12 months
Secondary	Overall survival (OS)	OS, defined as time from diagnosis to death	18 months