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Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070070
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : July 22, 2013
National Cancer Institute (NCI)
Information provided by:
Ludwig Institute for Cancer Research

Brief Summary:

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 or disease Intervention/treatment Phase
Bladder Cancer Biological: BCG vaccine Biological: NY-ESO-1 peptide vaccine Biological: sargramostim Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (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
Actual Primary Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • 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


  • Bilirubin no greater than 2 mg/dL
  • AST and ALT less than 2.5 times upper limit of normal


  • Creatinine no greater than 1.8 mg/dL


  • No New York Heart Association class III or IV heart disease


  • No history of immunodeficiency disease
  • No history of autoimmune disease


  • 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


Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No prior bone marrow or peripheral blood stem cell transplantation


  • 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


  • More than 4 weeks since prior radiotherapy


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070070

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
National Cancer Institute (NCI)
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Principal Investigator: Dean F. Bajorin, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Harry W. Herr, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00070070    
Other Study ID Numbers: CDR0000329920
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013
Keywords provided by Ludwig Institute for Cancer Research:
transitional cell carcinoma of the bladder
stage I bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic