Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
NCT00070070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2022-10-12
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.
Conditions
- Transitional Cell Carcinoma
Interventions
- BIOLOGICAL
-
TICE®-strain BCG
- BIOLOGICAL
-
NY-ESO-1 protein
- BIOLOGICAL
-
sargramostim
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Ludwig Institute for Cancer Research
lead OTHER
Principal Investigators
-
Dean F. Bajorin, MD · Memorial Sloan Kettering Cancer Center
-
Harry W. Herr, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-28
- Primary Completion
- 2006-01-03
- Completion
- 2013-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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