Spinal chemotherapy may block deadly brain cancer spread
NCT ID NCT07511725
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding a chemotherapy drug (thiotepa) directly into the spinal fluid can prevent glioblastoma from spreading to the brain and spinal cord lining. The study enrolls 38 newly diagnosed patients whose tumors touch brain fluid spaces or whose surgery accidentally opened those spaces. Participants receive standard treatment plus six weekly spinal injections of thiotepa, and researchers will track survival and side effects for two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thiotepa (chemotherapy given into the spinal fluid)
- What this could lead to
- If it works, this could reduce the risk of cancer spreading in the brain and spinal cord lining, potentially extending survival for glioblastoma patients.
- What could go wrong
- This is a small, early-phase pilot study with only 38 participants, so results may not apply broadly. Adding chemotherapy to the spine carries risks like infection, bleeding, or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75 years, either sex. * Histologically confirmed newly-diagnosed WHO grade IV glioblastoma with at least one measurable lesion on MRI. * Must fulfil ONE of the following high-risk imaging/surgical conditions: 1. Pre-operative MRI showing tumour in direct contact with the lateral ventricular sub-ventricular zone (SVZ+); OR 2. Operative record and post-operative imaging documenting an intra-operative cerebro-spinal-fluid leak (ventricular entry, VE). * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥ 3 months. * Neurological symptoms stable for ≥ 7 days before enrollment. * Adequate bone-marrow reserve: neutrophils ≥ 1.5 × 10⁹/L, haemoglobin ≥ 90 g/L, platelets ≥ 75 × 10⁹/L. * Coagulation acceptable: PT/INR and aPTT ≤ 1.5 × upper limit of normal (ULN). Hepatic: total bilirubin ≤ 1.5 × ULN, ALT \& AST ≤ 1.5 × ULN, albumin ≥ 30 g/L. Renal: serum creatinine ≤ 2 × ULN and calculated or 24-h creatinine clearance ≥ 50 mL/min. * Reliable contraception from first dose until 3 months after the last dose for both sexes. Exclusion Criteria: * Pregnant or lactating women. * Active infection requiring intravenous antibiotics within 7 days before study entry, or therapeutic anticoagulation with warfarin. * History of any other malignancy within the previous 5 years (except adequately treated basal-cell carcinoma of skin or cervical carcinoma in-situ). * Known HIV infection, AIDS, immunodeficiency syndromes, or active autoimmune disease needing systemic therapy. * Severe medical, neurological or psychiatric conditions that would preclude compliance with protocol procedures. * Disrupted ventricular drainage catheter or anatomical contraindication preventing safe lumbar puncture or Ommaya reservoir placement. * Uncontrolled chronic illnesses: diabetes, congestive heart failure (NYHA III/IV), hepatic cirrhosis, chronic kidney disease stage ≥ 3b, etc. * Any condition judged by the investigator to increase the risks of intrathecal chemotherapy or to confound toxicity assessment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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2nd Affiliated Hospital, School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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