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Suspended NCT06169280

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

Conditions: Glioma, Malignant, New Diagnosis Tumor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: Northwestern University

Location: Northwestern University Chicago Illinois

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of a high-grade glioma (WHO grade 3 or grade 4). * Patients must have presumed high grade glioma (WHO grade 3 or 4) based on clinical and radiologic evaluation for registration. * 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). * Tumor must be accessible for injection and must not be located in the brainstem or contained within the ventricular system. * Planning to undergo standard radiation/chemotherapy. * 18 years of age or older. * Performance status (PS) must be WHO PS of \< 2. * Stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg/day for the 5 days prior to inclusion * Serum glutamic-oxaloacetic transaminase (SGOT or AST) \< 3x upper limit of normal * Serum creatinine \< 2mg/dl * Platelets \> 100,000/mm3 and white blood cells (WBCs) \> 3000/mm3 Exclusion Criteria: * Prior or ongoing liver disease including known cirrhosis. * Known hepatitis B or C infection, known HIV infection. * Chronic use of immunosuppressive drugs (with exception of corticosteroids required for mass effect). * Acute viral, bacterial or fungal infections requiring therapy. * Pregnant or breast-feeding patients. * Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers). * Prior radiation therapy to the brain or prior treatment for brain tumor.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06169280). StuddyBuddy aggregates publicly available trial information.