drugset / Trial / NCT00072137

Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy

NCT00072137

Phase 1 Terminated 21 enrolled National Cancer Institute (NCI)
Parallel-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of vaccine therapy given directly into the bladder in treating patients who are undergoing surgery to remove all or part of the bladder. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving a vaccine directly into the bladder before surgery may cause a stronger immune response and keep tumor cells from coming back after surgery.

Timeline

Start
2003-10
Primary completion
2009-12
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Fowlpox GM-CSF Vaccine Adjuvant Vaccine Other
Subject recombinant fowlpox-TRICOM vaccine Vaccine Other