Vaccination of prostate cancer patients with modified vaccinia ankara delivering the tumor antigen 5T4 (TroVax): a phase 2 trial.

摘要: The attenuated vaccinia virus, modified Ankara, has been engineered to deliver the tumor antigen 5T4 (TroVax). TroVax evaluated in an open-label phase 2 trial hormone refractory prostate cancer patients which vaccine was administered either alone or combination with granulocyte macrophage-colony stimulating factor (GM-CSF). comparative safety and immunologic clinical efficacy of GM-CSF determined. Twenty-seven metastatic were treated (n=14) TroVax+GM-CSF (n=13). 5T4-specific cellular humoral responses monitored throughout study. Clinical assessed by quantifying prostate-specific concentrations measuring changes burden computer-assisted tomography scan. well tolerated all no serious adverse events attributed vaccination. Of 24 immunologically evaluable patients, mounted antibody responses. Periods disease stabilization from >10 months observed. Time progression significantly greater who compared those did not (5.6 vs. 2.3 mo, respectively). There objective seen this In study, showed similar alone. high frequency immune relationship enhanced time is encouraging warrants further investigation.