A Screening Protocol for IRB-Approved Vaccine Trials
Condition: Brain tumor
Key Inclusion Criteria
- Adults and children identified as having a probable brain tumor which is best treated by surgical resection
- Informed consent for:
- processing of brain tumor removed during surgery
- storing brain tumor tissue for possible inclusion in vaccine trials
Key Exclusion Criteria
- Women who are pregnant
Full Study Name
A Screening Protocol to Determine Potential Eligibility of Patients with Brain Tumors for IRB-Approved Vaccine Trials (IRB no. 09225)
The purpose of this study is to collect brain tumor samples taken during a scheduled surgical procedure to determine possible eligibility and interest in participating in current IRB-approved vaccine trials. The tumor tissue will be removed during the surgery regardless of research participation. The processed tumor tissue would then be maintained in a separate registry and analyzed for eligibility in any of the IRB-approved vaccine trials.
Financial Disclosure: Ray Chu, MD, and Keith Black, MD, who are co-investigators on this study, have a financial relationship with Immunocellular Therapeutics, Ltd. (ICT), the company that is sponsoring one of the approved vaccine trials. Christopher Wheeler, MD, who is a co-investigator on this study, is the inventor and holder of a patent application that was licensed to ICT. In addition, Cedars-Sinai is a significant shareholder of ICT, which is the sponsor providing financial support to manufacture the vaccines used in the trial.