drugset / Trial / NCT00070070
Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
Phase 1
Completed
6 enrolled
Ludwig Institute for Cancer Research
National Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |