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

This study has been completed.
Sponsor:
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00106158
First received: March 21, 2005
Last updated: November 4, 2010
Last verified: August 2007
  Purpose

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 Intervention Phase
Neoplasms
Biological: protein vaccination
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • tumor responses

Estimated Enrollment: 9
Study Start Date: June 2004
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106158

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

Publications:

ClinicalTrials.gov Identifier: NCT00106158     History of Changes
Other Study ID Numbers: LUD2002-005
Study First Received: March 21, 2005
Last Updated: November 4, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ludwig Institute for Cancer Research:
cancer/testis antigen
cancer vaccine
recombinant protein

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014