Actively Recruiting
Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma
Led by Northwestern University · Updated on 2025-10-06
20
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a high-grade glioma (WHO grade 3 or grade 4).
- Presumed high grade glioma based on clinical and radiologic evaluation.
- Pathologic confirmation of high grade glioma at stereotactic biopsy before NSC-CRAd-S-pk7 injection.
- Tumor accessible for injection and not located in brainstem or ventricular system.
- Planning to undergo standard radiation and chemotherapy.
- Age 18 years or older.
- WHO performance status less than 2.
- Stable or decreasing corticosteroid dose (equivalent to 64 6 mg/day) for 5 days prior to inclusion.
- Serum glutamic-oxaloacetic transaminase (SGOT or AST) less than 3 times upper limit of normal.
- Serum creatinine less than 2 mg/dl.
- Platelets above 100,000/mm3 and white blood cells above 3000/mm3.
You will not qualify if you...
- Prior or ongoing liver disease including cirrhosis.
- Known hepatitis B or C infection or HIV infection.
- Chronic use of immunosuppressive drugs except corticosteroids for mass effect.
- Acute infections requiring therapy.
- Pregnant or breastfeeding.
- Evidence of metastatic disease or other malignancies except certain skin cancers.
- Prior brain radiation therapy or brain tumor treatment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
N
Neurological Surgery
CONTACT
R
Roger Stupp, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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