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Safety Study of NY-ESO-1 Protein Vaccine to Treat Cancer Expressing NY-ESO-1

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: NCT00106158
Recruitment Status : Completed
First Posted : March 22, 2005
Last Update Posted : November 5, 2010
Information provided by:
Ludwig Institute for Cancer Research

Brief Summary:
The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1 specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients with cancer expressing NY-ESO-1.

Condition or disease Intervention/treatment Phase
Neoplasms Biological: protein vaccination Phase 1

Detailed Description:

NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries (SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse transcription-polymerase chain reaction (RT-PCR) analysis showed that NY-ESO-1 displayed the typical expression pattern of CT antigens. NY-ESO-1 mRNA was expressed only in testis of normal tissues tested and in various types of cancer, including lung cancer, breast cancer, malignant melanoma and bladder cancer. LAGE-1 was identified by the representational difference analysis and revealed to display 84% amino acid homology with NY-ESO-1. In most cases, expression of LAGE-1 parallels the expression of NY-ESO-1. Since testis is an immune privileged organ where HLA molecules are not expressed, these antigens can be considered tumor-specific.

Because of frequent NY-ESO-1 mRNA expression and high immunogenicity in advanced cancer, NY-ESO-1 is an attractive target molecule for a cancer vaccine. Current therapies against advanced cancer have limited effectiveness. The idea of vaccination with NY-ESO-1 protein in cancer patients with tumors expressing NY-ESO-1 mRNA is based on two findings: 1) the number of CD8+ T cell epitopes identified in NY-ESO-1 molecule are limited to those binding to HLA-A0201, A31, Cw3 and Cw6. These HLA subtypes are carried by a minor Japanese population; 2) CD8+ T cell responses specific to NY-ESO-1 are polyclonal. Protein vaccination may induce immune response more effectively against tumors expressing NY-ESO-1 than peptide immunization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunization of Patients With Tumors Expressing NY-ESO-1 or LAGE Antigen With Complex of NY-ESO-1 Protein and Cholesterol-bearing Hydrophobized Pullulan (CHP)
Study Start Date : June 2004
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  1. NY-ESO-1-specific immune responses

Secondary Outcome Measures :
  1. tumor responses

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically proven cancer
  • Confirmed NY-ESO-1 expression
  • No other effective therapy available
  • 4 weeks since conventional therapy before start of the current protocol
  • Performance status < 2 (ECOG scale)
  • Age > 18
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Serious illness
  • Metastatic diseases to central nervous system
  • Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or NSAIDs
  • HIV positive
  • Mental impairment that may compromise the ability to give written informed consent
  • Pregnancy and breastfeeding

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): NCT00106158

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Dept. of Immunology, Okayama University School of Medicine and Dentistry
Okayama, Japan, 700-8558
Sponsors and Collaborators
Ludwig Institute for Cancer Research
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Principal Investigator: Eiichi Nakayama, MD., PhD Dept. of Immunology, Okayama University Schhol of Medicine and Dentistry


Layout table for additonal information Identifier: NCT00106158     History of Changes
Other Study ID Numbers: LUD2002-005
First Posted: March 22, 2005    Key Record Dates
Last Update Posted: November 5, 2010
Last Verified: August 2007
Keywords provided by Ludwig Institute for Cancer Research:
cancer/testis antigen
cancer vaccine
recombinant protein
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs