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Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder
This study is ongoing, but not recruiting participants.
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070070
  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.


Condition Intervention Phase
Bladder Cancer
Biological: BCG vaccine
Biological: NY-ESO-1 peptide vaccine
Biological: sargramostim
Phase I

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Sargramostim BCG Vaccine
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070070

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Dean F. Bajorin, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Harry W. Herr, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
transitional cell carcinoma of the bladder
stage I bladder cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009