TOCA 5™: Phase 2/3 Trial for Recurrent GBM or AA


Brain cancers, such as glioblastoma and anaplastic astrocytoma, often regrow despite initial treatment. Participation in a clinical trial is one possible option for people who have regrowth of these types of brain cancers. It is recommended that patients talk with their doctor to discuss potential participation in a clinical trial.

Tocagen is conducting a clinical trial, called “Toca 5”, for patients with recurrent glioblastoma or anaplastic astrocytoma who are planning to have their tumor removed surgically. After reading the information below, please click on the patient inquiry button at the bottom of this page to learn more potential participation in the Toca 5 trial.

The Toca 5 clinical trial is intended to determine if the investigational products, Toca 511 & Toca FC, as a combination treatment is effective (works) and safe, compared to a selected number 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 carries instructions 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).

This Phase 2/3 study focuses on patients who are undergoing resection for first or second recurrence of glioblastoma or anaplastic astrocytoma. If the subject is qualified to participate in the study, he/she will be randomly assigned to either Toca 511 & Toca FC or Standard of Care (control treatment) including physician selection of single agent lomustine, temozolomide, or bevacizumab. In order to participate in this study, subjects must have a tumor that can be measured preoperatively and the surgeon estimates that at least 80% of the tumor can be removed at surgery. If the subject is assigned to Toca 511 & Toca FC, then immediately following removal (“resection”) of the tumor, Toca 511 will be injected into the wall of the resection cavity. After allowing time for the virus to spread through residual tumor, subjects begin taking cycles of Toca FC. If the subject is assigned to the standard of care arm, the subject will have surgery for removal of the tumor, and then approximately 6 weeks after surgery, the subject will begin taking single agent lomustine, temozolomide, or bevacizumab. The focus of this study is to compare the overall survival of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumor resection.

A patient may qualify for this study if the patient:

  • has glioblastoma or anaplastic astrocytoma at 1st or 2nd recurrence (including this recurrence)
  • is between 18 years old and 75 years old
  • has a Karnofsky performance score ≥ 70 (at minimum, can care for self)
  • has a tumor ≤ 5cm
  • has not had prior bevacizumab for recurrence

Currently, this study is being offered in the United States and Canada.

For a full list of entry criteria and participating study site locations please click here or paste this link into your browser:

Patient Inquiry For Toca 5 Study

Learn more about how Toca 511 & Toca FC is designed to work

Toca 511 & Toca FC: Proposed Mechanism of Action

Toca 511 & Toca FC are investigational products. An investigational product is one that has not been proven to be safe and effective for this use and is not licensed by the US Food and Drug Administration or any other government agency. An investigational product can only be administered in a research study.