Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT07145112
Status:
RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1 study evaluating the safety and feasibility of laser interstitial thermal therapy (LITT) followed by lomustine (CCNU) for recurrent glioblastoma in adults. The primary aim is to evaluate the safety of the combination of LITT plus lomustine based on the assessment of treatment-related adverse events and the feasibility of completing LITT + lomustine in the proposed timeframe. The secondary aim is to assess overall survival for up to 2 years after the first dose of lomustine.
Detailed Description:
The LITT procedure is performed per standard of care under general anesthesia using a stereotactic neurosurgical approach where a laser catheter is precisely inserted into the tumor under MRI guidance. Real-time MRI thermometry is used to ensure controlled tumor ablation while minimizing damage to adjacent structures. Patients typically undergo postoperative MRI to assess treatment response, and most can be discharged within 24-48 hours, facilitating early initiation of adjuvant therapy.
Approximately 7 days following LITT, lomustine is administered per standard of care on Day 1 for a total of one cycle.
Participants will be monitored for serious and non-serious adverse events (AE) starting from initiation of LITT per institutional practices. All follow-up is based on standard of care for LITT and lomustine.
Approximately 7 days following LITT, lomustine is administered per standard of care on Day 1 for a total of one cycle.
Participants will be monitored for serious and non-serious adverse events (AE) starting from initiation of LITT per institutional practices. All follow-up is based on standard of care for LITT and lomustine.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2025-06916 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2352196 | OTHER | UC Davis IRB | View |