Stupp treatment plus intrathecal thiotepa for glioblastoma with ventricular or meningeal spread

Stupp Regimen Combined With Intrathecal Injection of Thiotepa for the Treatment of Glioblastoma With Ventricular Invasion or Meningeal Metastasis：a Prospective, Single-Arm, Exploratory Study

This trial will test whether adding intrathecal thiotepa to the Stupp regimen and radiotherapy helps adults with glioblastoma that has spread into the brain ventricles or meninges.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07193654 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study adds intrathecal thiotepa to standard care (maximal surgical resection, radical radiotherapy, and temozolomide per the Stupp regimen) for adults with newly diagnosed WHO grade 4 glioblastoma and imaging or CSF evidence of ventricular or meningeal involvement. Participants undergo surgery, receive radical radiotherapy and concomitant/adjuvant oral temozolomide, and are given intrathecal thiotepa injections via ventricular or cisternal access. Key outcomes include progression-free survival and overall survival, with safety monitoring of neurologic status and laboratory parameters. Results will be compared to standard treatment outcomes to determine whether the added intrathecal therapy improves tumor control in this high-risk subgroup.

Who should consider this trial

Good fit: Adults 18–75 with newly diagnosed WHO grade 4 glioblastoma, imaging or CSF evidence of ventricular or meningeal invasion, prior maximal resection (with ventricular/cisternal opening), and adequate organ function are the intended candidates.

Not a fit: Patients without ventricular or meningeal involvement, those with poor organ function, active uncontrolled infection, or who are pregnant or breastfeeding would likely not receive benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could prolong progression-free and overall survival for patients whose glioblastoma has invaded the ventricles or meninges.

How similar studies have performed: Intrathecal chemotherapy has shown mixed results in leptomeningeal disease from other cancers, and adding intrathecal thiotepa specifically to the Stupp regimen for GBM with ventricular/meningeal spread is relatively novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Aged 18 - 75, any gender.
* Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion, imaging suggesting ventricular or meningeal invasion.
* History of intraoperative intraventricular or cisternal opening.
* Malignant cells found in cerebrospinal fluid pre-radiotherapy.
* ECOG score 0 - 2, expected survival≥3 months.
* Stable neurological symptoms for over 7 days.
* Neutrophil count≥1.5×10⁹/L, hemoglobin≥90 g/L, platelet count≥75×10⁹/L.
* PT/INR and PTT≤1.5×upper limit of normal.
* Total bilirubin≤1.5×upper limit of normal, AST and ALT≤1.5×upper limit of normal, albumin≥30 g/L, creatinine≤2×upper limit of normal, calculated or 24-hour urine creatinine clearance rate≥50 mL/min.
* Agree to effective contraception from first to 3 months after last dose.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Active infection within 7 days before starting study drug requiring IV antibiotics or therapeutic warfarin.
* Other malignancies in past 5 years.
* HIV/AIDS history; past immunodeficiency, or active autoimmune disease needing systemic treatment.
* Severe medical, neurological, or psychiatric conditions preventing full adherence to study treatment or assessments.
* Ventricular drainage tube rupture or inability to undergo lumbar puncture.
* Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Ting Zhang, phD.

Conditions: Glioblastoma, brain ventricles invasion, meningeal metastasis, Intrathecal chemotherapy