Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	MSKCC-03047 LUDWIG-LUD2002-004, NCT00070070

Objectives

1. 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.
2. Determine the immunological profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Neutrophil count at least 1,500/mm³
• Lymphocyte count at least 500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dean Bajorin, MD, Principal investigator		Ph: 646-422-4333; 800-525-2225
Harry Herr, MD, Principal investigator		Ph: 646-422-4411; 800-525-2225 Email: herrh@mskcc.org

Registry Information
Official Title		NY-ESO-1 Protein Immunization of Post-Cystectomy Patients with Transitional Cell Carcinomas Expressing NY-ESO-1 or LAGE-1 Antigen
Trial Start Date		2003-05-27
Registered in ClinicalTrials.gov		NCT00070070
Date Submitted to PDQ		2003-08-12
Information Last Verified		2006-04-01
NCI Grant/Contract Number		CA08748

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