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

Study Purpose

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。

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07193654
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma (GBM)
Additional Details

Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, with a dismal prognosis despite standard treatment. The standard treatment for GBM, which includes surgery, radiotherapy, and chemotherapy with temozolomide (known as the Stupp regimen), has remained largely unchanged for over two decades. Patients with GBM who have tumor invasion of the brain ventricles or meningeal metastasis face an even worse prognosis, with significantly shorter progression-free survival and overall survival compared to patients without these complications. The blood-brain barrier poses a significant challenge to effective chemotherapy delivery, limiting the efficacy of systemic treatments for central nervous system tumors. Intrathecal chemotherapy administration represents a promising strategy to overcome this barrier by directly delivering chemotherapeutic agents into the cerebrospinal fluid, potentially improving tumor control and survival outcomes in patients at high risk for intraventricular dissemination.

Arms & Interventions

Arms

Experimental: Stupp plus intrathecal injection of thiotepa

Interventions

Drug: - Intrathecal injection of thiotepa

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

Drug: - Stupp regimen (oral temozolomide)

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;

Radiation: - Radical radiotherapy

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

Procedure: - Maximal surgical resection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou 1808926, Zhejiang 1784764, China

Status

Recruiting

Address

2nd Affiliated Hospital, School of Medicine

Hangzhou 1808926, Zhejiang 1784764, 310000

Site Contact

Ting Zhang phD

[email protected]

+86571-87783521

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