High Grade GliomaEarly Phase 1NCT05773326
Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG
A Early Phase 1 study testing Temsirolimus in people with High Grade Glioma and Glioma, run by Nader Sanai at 1 site in United States.
Trial summary
This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma, Glioma, Glioma, Malignant
- What is being tested?
- Temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 16 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma
This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion. Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor.
- Conditions
- High Grade Glioma, Glioma, Glioma, Malignant, Glioblastoma
- Being tested
- Temsirolimus
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Also called Torisel
TORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Single infusion of Temsirolimus | Experimental | Single infusion of Temsirolimus via super-selective intra-arterial infusion or IV Receives: Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor pharmacokinetics (PK) of temsirolimus
Total and unbound temsirolimus concentration in tumor tissue.
Measured: Day 1 (Intraoperative)
Secondary outcomes (1)
Pharmacodynamic effects of temsirolimus
Quantification of the % of pS6 positive cells
Measured: Day 1 (Intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start15 May 2023
- Primary completion28 Feb 2025
- Study completion16 Oct 2025
Why it stopped: Study terminated due to unavailability of the investigational product required to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nader Sanai, MD, Principal investigator, Chief Scientific Officer/Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773326
- Sponsor's protocol ID
- 2022-17
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma
- ClinicalTrials.gov ID
- NCT05773326
- Acronym / sponsor ID
- 2022-17
- Conditions
- High Grade Glioma, Glioma, Glioma, Malignant, Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to unavailability of the investigational product required to continue the study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center
- Study start
- 15 May 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion. Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single infusion of Temsirolimus | Experimental | Drug: TemsirolimusSingle infusion of Temsirolimus via super-selective intra-arterial infusion or IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusAlso: ToriselTORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. | Drug | Single infusion of Temsirolimus |
Primary outcome
Tumor pharmacokinetics (PK) of temsirolimus
Time frame: Day 1 (Intraoperative)
Total and unbound temsirolimus concentration in tumor tissue.
1 secondary outcome
Pharmacodynamic effects of temsirolimus
Time frame: Day 1 (Intraoperative)
Results and safety
The study was stopped early (reason given: Study terminated due to unavailability of the investigational product required to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Ivy Brain Tumor Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Sanai, MD principal investigator
Chief Scientific Officer/Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Temsirolimus in people with High Grade Glioma and Glioma, run by Nader Sanai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to unavailability of the investigational product required to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor pharmacokinetics (PK) of temsirolimus (time frame: Day 1 (Intraoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.