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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: This research study is evaluating an investigational drug 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 Summary:

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 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.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Maximum Tolerated Dose [ Time Frame: Minimum of 21 Days ]

The primary objective is to determine the maximum tolerated dose of rQNestin34.5v.2 injected into recurrent malignant gliomas, with or without previous immunomodulation with cyclophosphamide.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • MRI Changes in Permeability [ Time Frame: Evaluated every 2 months for 1 year ]
    Determine MRI alterations of permeability in injected sites using standard perfusion sequences.
  • MRI Changes in Volume [ Time Frame: Evaluated every 2 months for 1 year ]
    Determine MRI alterations of cerebral blood volume in injected sites using standard sequences.
  • MRI Changes in Flow [ Time Frame: Evaluated every 2 months for 1 year ]
    Determine MRI alterations of cerebral blood flow in injected sites using standard sequences.
  • Viral Shedding in Saliva [ Time Frame: Evaluated up to day 56 for each subject ]
    Assess the shedding of rQNestin34.5v.2 in the saliva of subjects treated with rQNestin34.5v.2
  • HSV1 Viremia [ Time Frame: Evaluated up to day 56 for each subject ]
    Assess the degree of HSV-1 viremia post rQNestin34.5v.2 administration
  • HSV1 Antibody Response [ Time Frame: Evaluated up to day 56 for each subject ]
    Identify changes in HSV1 antibody response


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: May 9, 2017
Date Started: June 1, 2017
Date Completion: August 1, 2023
Last Updated: May 12, 2017
Last Verified: May 2017