Trial ID or NCT#

NCT02414165

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to determine if the investigational products, Toca 511 and Toca FC, as a combination treatment is effective (works) and safe, compared to a selectednumber of approved treatments for brain tumors, called a control treatment. Toca 511 is a live virus that has been built to carry a gene into cancer cells. This gene carriesinstructions that cause the cancer cells to turn Toca FC into a drug that may kill the cancer cells. Toca FC is an investigational extended-release form of flucytosine (5-FC). Flucytosine is a drug approved to treat fungal infections; however, it is not approved for the treatment of brain tumors.

Official Title

A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD
Neuro-oncologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Melanie G Hayden Gephart
Gordon Li, MD
Gordon Li, MD
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)
Reena Thomas
Reena Thomas
Neuro-oncologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery

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CONTACT

CCTO
(650) 498-7061