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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070070 |
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.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer |
Biological: BCG vaccine Biological: NY-ESO-1 peptide vaccine Biological: sargramostim |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study ID Numbers: | CDR0000329920, MSKCC-03047, LUDWIG-LUD2002-004 |
Study First Received: | October 3, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00070070 History of Changes |
Health Authority: | United States: Federal Government |
transitional cell carcinoma of the bladder stage I bladder cancer |
BCG Vaccine Urinary Tract Neoplasm Cystocele Immunologic Factors Urinary Bladder Diseases Adjuvants, Immunologic Urinary Bladder Neoplasms Urogenital Neoplasms |
Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma Urologic Diseases Bladder Neoplasm Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
BCG Vaccine Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Urinary Bladder Diseases Urinary Bladder Neoplasms Adjuvants, Immunologic Urogenital Neoplasms |
Carcinoma, Transitional Cell Urologic Neoplasms Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Urologic Diseases Neoplasms, Glandular and Epithelial |