drugset / Trial / NCT00070070

Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas

NCT00070070

Non-randomizedSequentialOpen-labelTreatment

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas.

Timeline

Start
2003-10-28
Primary completion
2006-01-03
Completion
2013-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG vaccine Vaccine 100000 unknown Intrathecal
Subject BCG vaccine Vaccine 1e+06 unknown Intrathecal
Subject NY-ESO-1 protein Vaccine 75 ug Intrathecal
Subject sargramostim Protein / enzyme biologic 100 ug Intrathecal