RECRUITING

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

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.

Conditions

Glioma, MalignantNew Diagnosis Tumor
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Related Conditions:

Glioma, MalignantNew Diagnosis Tumor

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Glioma, Malignant
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Roger Stupp, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2030-12-31