Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG

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.

Trial Details

NCT ID
NCT05773326
Phase
EARLY_PHASE1
Sponsor
Nader Sanai
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Temsirolimus
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404

Key Eligibility 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 usin…
  • 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 pe…

For full eligibility, visit ClinicalTrials.gov.

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