Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as BCG and sargramostim, 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 cancer of the bladder.
|Bladder Cancer||Biological: BCG vaccine Biological: NY-ESO-1 peptide vaccine Biological: sargramostim||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NY-ESO-1 Protein Immunization of Post-Cystectomy Patients With Transitional Cell Carcinomas Expressing NY-ESO-1 or LAGE-1 Antigen|
|Study Start Date:||May 2003|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- Determine the safety and tolerability of NY-ESO-1 peptide vaccine, BCG, and sargramostim (GM-CSF) in post-cystectomy patients with transitional cell carcinoma of the bladder expressing NY-ESO-1 or LAGE-1 antigen.
- Determine the immunological profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive NY-ESO-1 peptide vaccine mixed with BCG intradermally (ID) once weekly on weeks 1 and 2. Patients then receive NY-ESO-1 peptide mixed with sargramostim (GM-CSF) ID once weekly on day 2 of weeks 3-6. Patients also receive GM-CSF subcutaneously alone on days 1, 3, 4, and 5 of weeks 3-6. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 and 6 weeks.
PROJECTED ACCRUAL: A total of 24-28 patients (8 HLA-A2 positive with prior intravesical BCG, 8 HLA-A2 positive without prior intravesical BCG, 4-6 HLA-A2 negative with prior intravesical BCG, and 4-6 HLA-A2 negative without prior intravesical BCG) will be accrued for this study within 15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070070
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Dean F. Bajorin, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Harry W. Herr, MD||Memorial Sloan Kettering Cancer Center|