Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the bladder - Tumor expression of NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) or immunohistochemistry OR LAGE-1 by RT-PCR - Prior cystectomy within the past 4-16 weeks - No evidence of disease by radiological imaging within the past month PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Neutrophil count at least 1,500/mm^3 - Lymphocyte count at least 500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL - No bleeding disorders Hepatic - Bilirubin no greater than 2 mg/dL - AST and ALT less than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.8 mg/dL Cardiovascular - No New York Heart Association class III or IV heart disease Immunologic - No history of immunodeficiency disease - No history of autoimmune disease Other - HIV negative - No prior severe reaction to PPD (at least 15 mm induration) - No other malignancy within the past 5 years that has been treated with extensive chemotherapy/radiotherapy, has the potential for immune dysfunction, or has evidence of metastasis at the time of study entry - No other serious illness - No serious infection requiring antibiotics - No mental disorder that would preclude the ability to give informed consent or comply with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy - No prior bone marrow or peripheral blood stem cell transplantation Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy Endocrine therapy - More than 30 days since prior corticosteroids - No concurrent systemic corticosteroids - Concurrent topical or inhalational steroids allowed Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - At least 5 days since prior antibiotics - More than 4 weeks since prior participation in another clinical study - No concurrent antihistaminic drugs - No concurrent nonsteroidal anti-inflammatory drugs except low doses for prevention of an acute cardiovascular event or pain control - No concurrent immunosuppressive agents


NCT ID:

NCT00070070


Primary Contact:

Principal Investigator
Dean F. Bajorin, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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