RECRUITING

Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG

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Conditions

High Grade GliomaGliomaGlioma, MalignantGlioblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-05-15
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05773326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically diagnosed high-grade glioma (Grade 3 or 4 per 2021 WHO criteria) in the frontal lobe.
  2. * 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).
  3. * Patients who have completed the Stupp regimen.
  4. * 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.
  5. * Sufficient biopsy or archival tissue to confirm eligibility
  6. * 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.
  7. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
  8. * Age ≥18 at time of consent.
  9. * Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale
  10. * Participant has adequate bone marrow and organ function
  11. * 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.
  12. * 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.
  13. * 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.
  14. * Agreement to adhere to Lifestyle Considerations throughout study duration
  1. * 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.
  2. * Pregnancy or lactation.
  3. * Known hypersensitivity to temsirolimus or its metabolites, polysorbate 80, or to any other component of temsirolimus.
  4. * 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 \[e.g. estimated creatinine clearance\]
  5. * 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
  6. * Treatment with another investigational drug or other intervention within 30 days prior to the planned treatment Day 1.

Contacts and Locations

Study Contact

Phase 0 Navigator
CONTACT
602-406-8605
research@ivybraintumorcenter.org

Principal Investigator

Nader Sanai, MD
PRINCIPAL_INVESTIGATOR
Chief Scientific Officer/Director

Study Locations (Sites)

St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States

Collaborators and Investigators

Sponsor: Nader Sanai

  • Nader Sanai, MD, PRINCIPAL_INVESTIGATOR, Chief Scientific Officer/Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-15
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-05-15
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • High Grade Glioma
  • Glioma
  • Glioma, Malignant
  • Glioblastoma