This bystander effect in turn may play an important role in the efficacy of the current Ad-IFN clinical trial for superficial bladder cancer now underway.
Based on the results of the present studies, a Phase I trial is being planned for superficial bladder cancer, which will involve a single initial treatment with Ad-IFNalpha/Syn3 and measurement of IFN in the urine over time as an indicator of adequate gene transfer and expression.
To identify new effective agents and develop novel approaches for the chemoprevention and treatment of superficial bladder cancer we investigated the effects of a combination of retinoids and interferon alpha-2a (IFN) on growth and apoptosis in bladder cancer cell lines.
These findings demonstrate that Ad-IFNalpha can overcome resistance to IFN-alpha protein both in vitro and in vivo and support evaluation of intravesical Ad-IFNalpha/Syn3 for the treatment of superficial bladder cancer.
Thirty-two patients with superficial bladder cancer underwent 6 weekly treatments with full-, one-third, or one-tenth-dose of BCG plus 50 or 100 MU of IFN-alpha2B based on prior BCG exposure and tolerance.