Infusion of Temsirolimus for High Grade Glioma Treatment
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 study is testing a new way to deliver a drug called temsirolimus to see if it can help people with recurrent high-grade glioma during their surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT05773326 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label, dose-escalating Phase 0 trial designed to evaluate the safety and efficacy of temsirolimus in patients with recurrent high-grade glioma. Participants will receive a single infusion of the drug either through super-selective intra-arterial infusion or intravenously on the same day as their planned surgical tumor resection. The study specifically targets the mTOR pathway, and eligibility requires histologically confirmed high-grade glioma with specific molecular characteristics. The trial aims to assess the potential benefits of localized drug delivery in treating this aggressive form of brain cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed recurrent high-grade glioma in the frontal lobe who have completed the Stupp regimen and meet specific molecular criteria.
Not a fit: Patients with low-grade gliomas or those who have not completed the Stupp regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with recurrent high-grade glioma by targeting the tumor more effectively.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting the mTOR pathway have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Nader Sanai, MD — Chief Scientific Officer/Director
- Study coordinator: Phase 0 Navigator
- Email: research@ivybraintumorcenter.org
- Phone: 602-406-8605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.