Actively Recruiting
Prophylactic Regimen With Intrathecal Thiotepa in SVZ-positive or Meningeal-risk Glioblastoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-06
38
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test whether adding preventive intrathecal chemotherapy (thiotepa) to the standard Stupp regimen can lower the risk of leptomeningeal metastasis (LM) and extend survival in patients with newly diagnosed glioblastoma (GBM) whose tumors touch the sub-ventricular zone (SVZ+) or whose surgery accidentally opened the ventricle (VE). The main questions it aims to answer are: Can six weekly intrathecal injections of thiotepa (10 mg) given during chemoradiotherapy increase the chance of remaining free of LM at one year? Does the approach also prolong overall survival and progression-free survival compared with historical controls? Is the combination safe and well-tolerated in this high-risk population? Participants will: Receive maximal safe tumor resection followed by standard radiotherapy (60 Gy/30 fractions) plus daily temozolomide (75 mg/m²). Begin thiotepa injections (via lumbar puncture or Ommaya reservoir) within 1 week of starting radiotherapy, repeated every 7 days for 6 doses. Continue standard adjuvant temozolomide (150-200 mg/m² days 1-5/28) for 6 cycles. Understand that all procedures, toxicities and survival will be tracked for 2 years, with MRI and clinical visits every 4-8 weeks. Provide CSF and blood samples for exploratory biomarkers that may predict response or resistance.
CONDITIONS
Official Title
Prophylactic Regimen With Intrathecal Thiotepa in SVZ-positive or Meningeal-risk Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Newly diagnosed WHO grade IV glioblastoma confirmed by tissue analysis
- Tumor touching the sub-ventricular zone on pre-operative MRI or documented cerebrospinal-fluid leak during surgery
- ECOG performance status between 0 and 2 with life expectancy of at least 3 months
- Stable neurological symptoms for at least 7 days before joining
- Adequate bone marrow function with specific neutrophil, hemoglobin, and platelet levels
- Acceptable blood clotting and liver and kidney function tests within specified limits
- Use of reliable contraception from first dose until 3 months after last dose for both males and females
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infection requiring IV antibiotics within 7 days before study start or use of warfarin blood thinner
- History of other cancers in the past 5 years except some skin or cervical cancers
- Known HIV infection, AIDS, immune system disorders, or active autoimmune diseases needing treatment
- Severe medical, neurological, or psychiatric problems that prevent following study procedures
- Problems with ventricular drainage catheter or anatomy preventing safe lumbar puncture or reservoir placement
- Uncontrolled chronic illnesses like diabetes, severe heart failure, advanced liver disease, or advanced kidney disease
- Any condition that increases risk from intrathecal chemotherapy or confuses toxicity evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang, phD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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