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PERFORMANCE (Glioblastoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study vaccine is safe for patients who are newly diagnosed with glioblastoma and to see which type of temozolomide schedule works best with the study vaccine.

What is the Condition Being Studied?

Newly diagnosed glioblastoma (brain cancer)

Who Can Participate in the Study?

Adults newly diagnosed with a type of brain cancer called glioblastoma who:
- Have had a complete or partial surgery for their brain cancer
- Are positive for antibodies to CMV
- Are on a stable or decreasing dose of steroids

Age Group
Adults

What is Involved?

If you choose to be in this study, you will:
- Have your blood tested for antibodies (substances produced by the body to fight infections) to a common virus called cytomegalovirus (CMV)
- Complete standard radiation and chemotherapy
- Be randomized (like the flip of a coin) to receive either:
-- Group 1: Standard additional treatment with temozolomide for 5 days of every month for 6-12 months
-- Group 2: Temozolomide for 21 days of every month
- Receive study vaccines every 2 weeks for the first 3 vaccines and then monthly. Study vaccines are given by injections (shots) in the leg

Study Details

Full Title
PERFORMANCE: Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
Principal Investigator
Protocol Number
IRB:PRO00034208
NCT:NCT02864368
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698