Safety Study of NY-ESO-1 Protein Vaccine to Treat Cancer... | NCT00106158

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

NCT00106158

Sponsor

Ludwig Institute for Cancer Research

Status

Completed

Last Update Posted

Nov 5, 2010Estimated

Enrollment

9Estimated

Phase

Phase 1

Conditions

Neoplasms

Interventions

protein vaccination

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Mar 21, 2005

First Submission Date that Met QC Criteria

Mar 21, 2005

First Posted Date

Mar 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2010

Last Update Posted Date

Nov 5, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Ludwig Institute for Cancer ResearchOTHER

Collaborators

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Estimated

Name	Type	Description	Arm Group Labels	Other Names
protein vaccination	Biological

Measure	Description	Time Frame
NY-ESO-1-specific immune responses

Measure	Description	Time Frame
tumor responses

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eiichi Nakayama, MD., PhD	Dept. of Immunology, Okayama University Schhol of Medicine and Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Immunology, Okayama University School of Medicine and Dentistry		Okayama		700-8558	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15586225	Background	Sato S, Noguchi Y, Wada H, Fujita S, Nakamura S, Tanaka R, Nakada T, Hasegawa K, Nakagawa K, Koizumi F, Ono T, Nouso K, Jungbluth A, Chen YT, Old LJ, Shiratori Y, Nakayama E. Quantitative real-time RT-PCR analysis of NY-ESO-1 and LAGE-1a mRNA expression in normal tissues and tumors, and correlation of the protein expression with the mRNA copy number. Int J Oncol. 2005 Jan;26(1):57-63.
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