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

Launched by NORTHWESTERN UNIVERSITY · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients who have recently been diagnosed with high-grade glioma, a type of aggressive brain tumor. The main goal is to see if giving repeated doses of a special virus combined with neural stem cells is safe and if it can help shrink the tumor, improve survival times, and enhance the quality of life for patients. Participants will first have a biopsy to confirm their diagnosis, followed by a series of treatments that include surgery, chemotherapy, and radiation, along with the new therapy given through injections into the brain.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of high-grade glioma (specifically WHO grade 3 or 4). They should also be planning to undergo standard treatments like chemotherapy and radiation. Patients who are pregnant, have certain infections, or previous brain treatments will not be eligible. Throughout the trial, participants can expect a structured treatment plan that includes monitoring their health closely to ensure safety and effectiveness. It's important to know that this study is not yet recruiting participants, so those interested will need to wait for updates.

Gender

ALL

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.