Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced 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
Second Affiliated Hospital, School of Medicine, Zhejiang University
38 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if a combined treatment approach can treat glioblastoma (GBM) with ventricular invasion or meningeal metastasis in adults. The main questions it aims to answer are: Does the combined treatment of radical radiotherapy, the Stupp regimen (oral temozolomide), and intrathecal injection of thiotepa improve progression-free survival compared to standard treatment alone? Does the combined treatment improve overall survival compared to standard treatment alone? Participants will: * Undergo maximal surgical resection of the tumor； * Receive radical radiotherapy； * Take oral temozolomide according to the Stupp regimen； * Receive intrathecal injections of thiotepa。
Eligibility
Inclusion Criteria10
- 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 Criteria7
- 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.
Interventions
Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.
Stupp regimen (oral temozolomide)::75 mg/m² daily during radiotherapy; 150-200 mg/m² daily for 5 days every 28 days for 6 cycles after radiotherapy;
Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;
Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07193654