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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00070070
First received: October 3, 2003
Last updated: July 18, 2013
Last verified: July 2013
  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 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Study Start Date: May 2003
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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
Ludwig Institute for Cancer Research
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

ClinicalTrials.gov Identifier: NCT00070070     History of Changes
Other Study ID Numbers: CDR0000329920, MSKCC-03047, LUDWIG-LUD2002-004
Study First Received: October 3, 2003
Last Updated: July 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Ludwig Institute for Cancer Research:
transitional cell carcinoma of the bladder
stage I bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014