New way to deliver chemo directly to brain tumors tested in small study
NCT ID NCT05773326
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a single dose of the cancer drug temsirolimus, given directly into the brain's blood supply, for people with recurrent high-grade glioma (a fast-growing brain tumor). Only 5 participants were enrolled, and the study was terminated early. The main goal was to measure how much drug reaches the tumor tissue, not to determine if it works as a treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- temsirolimus (a cancer drug given directly into the brain's blood supply)
- What this could lead to
- If it works, this could point toward a more targeted way to deliver chemotherapy for aggressive brain tumors.
- What could go wrong
- This is a very early, tiny trial (only 5 people) that was terminated early. It only tests drug levels, not whether the drug actually helps patients live longer.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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5 people
The number who actually took part.
- Started
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May 2023
- Finished
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Oct 2025
- 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 years and older
- 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: * Histologically diagnosed high-grade glioma (Grade 3 or 4 per 2021 WHO criteria) in the frontal lobe. * Tissue must demonstrate mTOR+: PTEN loss OR PIK3C2B or AKT3 amplification on aCGH OR mutations for PIK3CA or PIK3R1, or mTOR or PTEN mutations using next-generation sequencing analysis OR pS6 positivity on immunohistochemistry (≥30% for pS6). * Patients who have completed the Stupp regimen. * Have measurable disease pre-operatively, defined as at least 1 contrast enhancing lesion, with 2 perpendicular measurements of at least 1 cm, as per RANO criteria. * Sufficient biopsy or archival tissue to confirm eligibility * Has voluntarily agreed to participate by giving written informed consent. Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures. * Age ≥18 at time of consent. * Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale * Participant has adequate bone marrow and organ function * Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause. * For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation until the end of treatment administration and for 3 months after the last dose of study drug. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner until the end of treatment administration and for 3 months after the last dose of study drug. * Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: * Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. * Pregnancy or lactation. * Known hypersensitivity to temsirolimus or its metabolites, polysorbate 80, or to any other component of temsirolimus. * Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, active infection, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance\] * Received a live vaccination or is in close contact with someone who received a live vaccination within 28 days of the start of study treatment * Treatment with another investigational drug or other intervention within 30 days prior to the planned treatment Day 1.
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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.
Contacts and locations
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Experimental therapy aims to turn brain tumors against themselves
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?