Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread

NCT07193654 | Recruiting Phase 2 DMC

• 1 other identifier: Y2025-0127
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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。

Conditions

Glioblastoma (GBM)

Keywords

brain ventricles invasion; meningeal metastasis; Intrathecal chemotherapy

Outcome Measures

Primary Outcomes (1)

• Safety assessment

  Incidence and severity of treatment-related adverse events using CTCAE 5.0.

  From first dose of study treatment until 30 days after last dose, assessed up to 52 weeks.

Secondary Outcomes (2)

• Progression-free survival

  3 months,6 months and 1 year after treatment

• Overall survival

  Until date of death from any cause, assessed up to 24 months.

Study Arms (1)

Stupp plus intrathecal injection of thiotepa

EXPERIMENTAL

Drug: Intrathecal injection of thiotepa; Drug: Stupp regimen (oral temozolomide); Radiation: Radical radiotherapy; Procedure: Maximal surgical resection

Interventions

Intrathecal injection of thiotepa DRUG

Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.

Stupp plus intrathecal injection of thiotepa

Stupp regimen (oral temozolomide) DRUG

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;

Stupp plus intrathecal injection of thiotepa

Radical radiotherapy RADIATION

Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;

Stupp plus intrathecal injection of thiotepa

Maximal surgical resection PROCEDURE

Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;

Stupp plus intrathecal injection of thiotepa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Meningeal Carcinomatosis

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ting Zhang, phD.

CONTACT

+86-571-87783521; zezht@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: September 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-03

Locations

CN (1)