Recurrent GlioblastomaPhase 1/2NCT05663125
LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
A Phase 1/2 study testing Laser interstitial thermal therapy and Temozolomide in people with Recurrent Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Laser interstitial thermal therapy and Temozolomide
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
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.
Read the 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.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Laser interstitial thermal therapy, Temozolomide
- Keywords
- GBM, Glioblastoma, LITT, Laser Interstitial Thermal Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser interstitial thermal therapyProcedure or surgery
Also called LITT
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
TemozolomideDrug
Also called TMZ
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.
| Study group | Role | What they receive |
|---|---|---|
| LITT with Early Application of Temozolomide | Experimental | Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT). Receives: Procedure: Laser interstitial thermal therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.
Measured: From Day 1 throughout the study until 3 months
Secondary outcomes (2)
Time to Progression (TTP)
TTP, defined as time from LITT to recorded tumor progression
Measured: 12 months
Overall survival (OS)
OS, defined as time from diagnosis to death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dabiao Zhou, MD, Beijing Tiantan Hospital
- Investigators
- Dabiao Zhou, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663125
- Sponsor's protocol ID
- KY2022-232-01
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
- ClinicalTrials.gov ID
- NCT05663125
- Acronym / sponsor ID
- KY2022-232-01
- Conditions
- Recurrent Glioblastoma
- Keywords
- GBM, Glioblastoma, LITT, Laser Interstitial Thermal Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LITT with Early Application of Temozolomide | Experimental | Procedure: Laser interstitial thermal therapy, Drug: TemozolomidePatients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser interstitial thermal therapyAlso: LITTAblation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation. | Procedure or surgery | LITT with Early Application of Temozolomide |
| TemozolomideAlso: TMZTemozolomide 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. | Drug | LITT with Early Application of Temozolomide |
Primary outcome
Adverse Events
Time frame: 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.
2 secondary outcomes
Time to Progression (TTP)
Time frame: 12 months
Overall survival (OS)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dabiao Zhou, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laser interstitial thermal therapy and Temozolomide in people with Recurrent Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From Day 1 throughout the study until 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.