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New treatment option for Glioblastoma (GBM)
Official title Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
ClinicalTrials.gov ID: NCT07193654
What this study is testing
What is Intrathecal injection of thiotepa?
Intrathecal injection of thiotepa is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma (gbm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.