NCT00106158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 5, 2010

Status Verified

August 1, 2007

First QC Date

March 21, 2005

Last Update Submit

November 4, 2010

Conditions

Neoplasms

Keywords

cancer/testis antigencancer vaccinerecombinant protein

Outcome Measures

Primary Outcomes (1)

  • NY-ESO-1-specific immune responses

Secondary Outcomes (1)

  • tumor responses

Interventions

protein vaccinationBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven cancer
  • Confirmed NY-ESO-1 expression
  • No other effective therapy available
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Immunology, Okayama University School of Medicine and Dentistry

Okayama, 700-8558, Japan

Location

Related Publications (5)

  • 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.

    PMID: 15586225BACKGROUND

  • Sugita Y, Wada H, Fujita S, Nakata T, Sato S, Noguchi Y, Jungbluth AA, Yamaguchi M, Chen YT, Stockert E, Gnjatic S, Williamson B, Scanlan MJ, Ono T, Sakita I, Yasui M, Miyoshi Y, Tamaki Y, Matsuura N, Noguchi S, Old LJ, Nakayama E, Monden M. NY-ESO-1 expression and immunogenicity in malignant and benign breast tumors. Cancer Res. 2004 Mar 15;64(6):2199-204. doi: 10.1158/0008-5472.can-03-3070.

    PMID: 15026363BACKGROUND

  • Nakada T, Noguchi Y, Satoh S, Ono T, Saika T, Kurashige T, Gnjatic S, Ritter G, Chen YT, Stockert E, Nasu Y, Tsushima T, Kumon H, Old LJ, Nakayama E. NY-ESO-1 mRNA expression and immunogenicity in advanced prostate cancer. Cancer Immun. 2003 Jul 31;3:10.

    PMID: 12889868BACKGROUND

  • Fujita S, Wada H, Jungbluth AA, Sato S, Nakata T, Noguchi Y, Doki Y, Yasui M, Sugita Y, Yasuda T, Yano M, Ono T, Chen YT, Higashiyama M, Gnjatic S, Old LJ, Nakayama E, Monden M. NY-ESO-1 expression and immunogenicity in esophageal cancer. Clin Cancer Res. 2004 Oct 1;10(19):6551-8. doi: 10.1158/1078-0432.CCR-04-0819.

    PMID: 15475443BACKGROUND

  • Kurashige T, Noguchi Y, Saika T, Ono T, Nagata Y, Jungbluth A, Ritter G, Chen YT, Stockert E, Tsushima T, Kumon H, Old LJ, Nakayama E. Ny-ESO-1 expression and immunogenicity associated with transitional cell carcinoma: correlation with tumor grade. Cancer Res. 2001 Jun 15;61(12):4671-4.

    PMID: 11406534BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Eiichi Nakayama, MD., PhD

    Dept. of Immunology, Okayama University Schhol of Medicine and Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2005

First Posted

March 22, 2005

Study Start

June 1, 2004

Study Completion

December 1, 2006

Last Updated

November 5, 2010

Record last verified: 2007-08

Locations

JP(1)