RECRUITING

Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma

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

The goal of this clinical trial is to learn about the safety and feasibility of administering repeated doses of neural stem cell (NSC)-conditionally replicative adenovirus (CRAd)-survivin (S)-protomer (p)k7, in persons with newly diagnosed high grade glioma. The main questions it aims to answer are: * whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible * how multiple doses of NSC-CRAd-S-pk7 influence tumor response, overall survival, time to tumor progression, and quality of life. Participants will: * undergo a biopsy to confirm high grade glioma, then receive the first dose of NSC-CRAd-S-pk7 into the brain * about 2 weeks later, undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain * start chemoradiation about 2 weeks after surgery, then about 2 weeks later, receive the 3rd dose of NSC-CRAd-S-pk7 into the brain * four weeks later, at the end of chemoradiation, receive a fourth dose of NSC-CRAd-S-pk7 into the brain. * after radiation is finished, receive standard of care chemotherapy and tumor-treating fields. Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks. Every other patient enrolled will receive N-acetylcysteine amide (NACA), from registration until the day prior to surgery and the second dose of NSC-CRAd-S-pk7.

Official Title

A Phase I Study of Repeated Neural Stem Cell-Based Virotherapy and Standard Radiation and Chemotherapy for Newly Diagnosed High-Grade Glioma

Quick Facts

Study Start:2025-06-27
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06169280

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. * Diagnosis of a high-grade glioma (WHO grade 3 or grade 4).
  2. * Patients must have presumed high grade glioma (WHO grade 3 or 4) based on clinical and radiologic evaluation for registration.
  3. * A pathologic confirmation of high grade glioma must be made at the time of stereotactic biopsy prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
  4. * Tumor must be accessible for injection and must not be located in the brainstem or contained within the ventricular system.
  5. * Planning to undergo standard radiation/chemotherapy.
  6. * 18 years of age or older.
  7. * Performance status (PS) must be WHO PS of \< 2.
  8. * Stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg/day for the 5 days prior to inclusion
  9. * Serum glutamic-oxaloacetic transaminase (SGOT or AST) \< 3x upper limit of normal
  10. * Serum creatinine \< 2mg/dl
  11. * Platelets \> 100,000/mm3 and white blood cells (WBCs) \> 3000/mm3
  1. * Prior or ongoing liver disease including known cirrhosis.
  2. * Known hepatitis B or C infection, known HIV infection.
  3. * Chronic use of immunosuppressive drugs (with exception of corticosteroids required for mass effect).
  4. * Acute viral, bacterial or fungal infections requiring therapy.
  5. * Pregnant or breast-feeding patients.
  6. * Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
  7. * Prior radiation therapy to the brain or prior treatment for brain tumor.

Contacts and Locations

Study Contact

Neurological Surgery
CONTACT
(312) 695-8143
braintumortrials@nm.org
Roger Stupp, MD
CONTACT
(312) 695-8143
roger.stupp@northwestern.edu

Principal Investigator

Roger Stupp, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Roger Stupp, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

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 Date2025-06-27
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2025-06-27
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Virotherapy
  • NSC-CRAd-S-pk7

Additional Relevant MeSH Terms

  • Glioma, Malignant
  • New Diagnosis Tumor