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LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Primary Purpose

Recurrent Glioblastoma

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Laser interstitial thermal therapy
Temozolomide
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring GBM, Glioblastoma, LITT, Laser Interstitial Thermal Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LITT with Early Application of Temozolomide

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse Events
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

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

Full Information

First Posted
December 14, 2022
Last Updated
December 22, 2022
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05663125
Brief Title
LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Official Title
Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
GBM, Glioblastoma, LITT, Laser Interstitial Thermal Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LITT with Early Application of Temozolomide
Arm Type
Experimental
Arm Description
Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).
Intervention Type
Procedure
Intervention Name(s)
Laser interstitial thermal therapy
Other Intervention Name(s)
LITT
Intervention Description
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
TMZ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.
Time Frame
From Day 1 throughout the study until 3 months
Secondary Outcome Measure Information:
Title
Time to Progression (TTP)
Description
TTP, defined as time from LITT to recorded tumor progression
Time Frame
12 months
Title
Overall survival (OS)
Description
OS, defined as time from diagnosis to death
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dabiao Zhou, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

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