LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Capital Medical University

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Recurrent Glioblastoma

Treatments: Drug: Temozolomide; Procedure: Laser interstitial thermal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05663125

KY2022-232-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

LITT with Early Application of Temozolomide

Experimental group

Description:

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

Treatment:

Procedure: Laser interstitial thermal therapy

Drug: Temozolomide