Can a Slow-Release chemo implant tackle an untreatable brain tumor?
NCT ID NCT07767110
First seen Aug 17, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This trial is testing whether a new formulation of the chemotherapy drug cisplatin, called LSAM-Cisplatin, can be safely infused directly into the brain tumors of children and young adults with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG). The treatment is given as a single infusion during a surgical procedure guided by real-time MRI. The study aims to find the safest dose and to see if the drug can shrink the tumor or slow its growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LSAM-Cisplatin, a slow-release form of the chemotherapy drug cisplatin, given as a single infusion directly into the tumor during MRI-guided surgery
- What this could lead to
- If it works, this approach could offer a new treatment option for a type of brain tumor that is currently very hard to treat, potentially improving outcomes for children and young adults.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the treatment may not be effective or may cause significant side effects. The study is primarily designed to test safety, not to prove benefit.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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3 to 21 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: * Aged 3 to ≤ 21 years. * Diagnosis of diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), based on characteristic magnetic resonance imaging (MRI) findings and/or histopathologic confirmation. * Prior radiation treatment must have included focal radiation therapy per institutional standard of care and must have been initiated within 6 weeks of diagnosis. * At least 4 weeks, but no more than 12 weeks, post-completion of radiotherapy treatment. * A standard of care post-radiation magnetic resonance imaging (MRI) performed 4 to 6 weeks after radiation therapy is required for confirmation of eligibility. * Performance status \[Karnofsky Performance Scale or Lansky Performance Score\] within 14 days of Day 1 ≥ 60. * Absence of other significant medical condition. * A legal parent/guardian and/or participant must be able to understand and be willing to sign a written informed consent and/or assent document, as appropriate. Exclusion Criteria: * Untreated symptomatic hydrocephalus at the time of consent, has metastatic or disseminated disease, or leptomeningeal disease. * Magnetic resonance imaging (MRI) findings that preclude stereotactic procedure. * Intercurrent illnesses or conditions which preclude participation: active systemic infections, autoimmune disease requiring systemic immunomodulation, active or uncontrolled seizure disorder, central nervous system (CNS) vasculopathy or aneurysms, Grade ≥3 cardiac dysfunction, Fridericia-corrected QT interval (QTcF) ≥470 ms. * Abnormal organ function: * Renal insufficiency: glomerular filtration rate (GFR) ≤ 60 mL/min/1.73m² (with Schwartz equation) * Hepatic dysfunction: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of liver metastases; or bilirubin ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of Gilbert disease * Bone marrow suppression: * absolute neutrophil count (ANC) \< 1,000/μL * platelets \< 100,000/μL * Coagulopathy or international normalized ratio (INR) \> 1.5 * Receiving any anticoagulants or antiplatelet drugs; any drugs known to cause ototoxicity and nephrotoxicity; receiving any other tumor-directed therapy. * Known allergy or hypersensitivity to the study agent (including cisplatin and diluent components). * Female participants of childbearing potential must not be pregnant or breast-feeding.
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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 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.
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