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LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05663125
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dabiao Zhou, MD
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: LITT with Early Application of Temozolomide

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, China

Status

Address

Beijing Tiantan Hospital

Beijing, ,

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