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NY-ESO-1 Protein Immunization of Post-Cystectomy Patients With Transitional Cell Carcinomas Expressing NY-ESO-1 or LAGE-1 Antigen

Phase 1
18 Years
Not Enrolling
Bladder Cancer

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Trial Information

NY-ESO-1 Protein Immunization of Post-Cystectomy Patients With Transitional Cell Carcinomas Expressing NY-ESO-1 or LAGE-1 Antigen


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Dean F. Bajorin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Bladder Cancer
  • transitional cell carcinoma of the bladder
  • stage I bladder cancer
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell



Memorial Sloan-Kettering Cancer Center New York, New York  10021