A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Brain Tumor
- Anaplastic Oligodendroglioma of Brain (Diagnosis)
- Astrocytoma
- Pylocytic/Pylomyxoid Astrocytoma
- Brain Cancer
- Ependymoma
- Ganglioglioma
- Glioblastoma
- Glioblastoma Multiforme
- Oligodendroglioma
- Glioma
- Malignant Astrocytoma
- Malignant Glioma of Brain
- Mixed Oligo-Astrocytoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: phase I, open-label, single center, dose-escalation, double arm clinical trial of an oncolytic virus called rQNestinMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis. "Investigational" means that the intervention is being studied. The FDA (the U.S. F...
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved rQNestin34.5v.2 as a treatment for any disease. This is the first time that rQnestin34.5v.2 will be given to humans. The research drug, rQNestin34.5v.2, is an oncolytic viral vector made from the herpes simplex virus type 1 (HSV1). The large majority of humans already have regular HSV1 in their nervous system. Normally, this virus can cause cold sores in areas like the lips, fingers and genitals in humans by making copies of itself in normal healthy cells. In some cases, HSV1 can cause severe infection of the brain and liver and/or death. However, scientists have removed or changed parts of the rQNestin virus being used on this study so it can only make copies of itself in glioma cells and not normal healthy cells. If it is effective, the rQNestin34.5v.2 drug will spread to a glioma cell, kill it, and then make a copy of itself and spread again. This should be repeated over and over until all glioma cells are reached. If rQNestin34.5v.2 moves into a normal brain cell, it should not grow and make copies, and therefore should not spread to other normal brain cells. The purpose of this research study is to test if rQnestin34.5v.2 is safe to use in humans, and if it is effective in treating malignant glioma. This study is also looking for the highest dose of rQNestin34.5v.2 that can be given safely to people with malignant brain tumors.
Tracking Information
- NCT #
- NCT03152318
- Collaborators
- National Institutes of Health (NIH)
- Candel Therapeutics, Inc.
- Investigators
- Principal Investigator: E. Antonio Chiocca, MD, PhD Brigham and Women's Hospital
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