NCT03152318

A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2

A Phase I Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2, a Genetically Engineered HSV-1 Virus, and Immunomodulation With Cyclophosphamide

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating an investigational drug, an oncolytic virus called rQNestin34.5v.2. 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 of recurrent or progressive brain tumor.

Detailed 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. 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.

Conditions

• Malignant Glioma of Brain
• Astrocytoma
• Malignant Astrocytoma
• Oligodendroglioma
• Anaplastic Oligodendroglioma of Brain (Diagnosis)
• Mixed Oligo-Astrocytoma
• Ependymoma
• Ganglioglioma
• Pylocytic/Pylomyxoid Astrocytoma
• Brain Tumor
• Glioma
• Brain Cancer
• Glioblastoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	rQNestin	rQNestin is an oncolytic viral vector. It is administered via intratumoral injection during biopsy surgery.
DRUG	Cyclophosphamide	Cyclophosphamide is an immunomodulating agent. It is administered intravenously in a single dose 2 days (+/- 6 hrs) before surgery.
PROCEDURE	Stereotactic biopsy	In both arms, subjects will undergo standard of care stereotactic biopsy in the intraoperative MRI operating room. The stereotactic needle will be placed stereotactically into the tumor bed using intraoperative MRI guidance to collect the biopsy, and again to administer the rQNestin oncolytic virus.

Timeline

• Start date: 2017-07-18
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2017-05-15
• Last updated: 2026-03-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study