Full 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 CyclophosphamidePurpose
Researchers are assessing a drug called rQNestin34.5v.2, for people with brain cancer that came back after treatment. The people in this study have a type of brain cancer called a glioma.
rQNestin34.5v.2 is made from the herpes simplex virus type 1 (HSV1). HSV1 is a virus that affects the nervous system and can cause cold sores. Most people already have regular HSV1 in their nervous systems. Researchers have removed or changed parts of the virus so it can only make copies of itself in glioma cells. It cannot multiply in healthy brain cells.
rQNestin34.5 is designed to spread to a glioma cell, kill it, make a copy of itself, and spread again. This is repeated until all glioma cells are reached. rQNestin34.5v.2 is injected directly into a tumor during surgery. If you join this study, you will get these injections 6 times over a period of 120 days.
Who Can Join
To join this study, there are a few conditions. You must:
- Have glioma that came back after treatment with radiation therapy and temozolomide.
- Have completed medical treatments at least 4 weeks before getting rQNestin34.5v.2. At least 12 weeks must pass since finishing radiation therapy.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call the Brain Tumor Hotline at 866-886-9807. You may also call Dr. Cameron Brennan’s office at 212-639-8268.