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OpenTrials
Completed

NCT Number: NCT00676949

Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors

The purpose of this study is to evaluate the clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

About this study

KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression profile analysis by the use of cDNA microarray in the previous studies. The investigators have determined the HLA-A*2402 restricted epitope peptides respectively derived from KOC1, TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated with the appropriate targets expressing the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore the investigators focused on the prevention of further expansion of the solid tumors highly expressing these 5 proteins using these 5 peptides.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of unresectable or relapsed gastrointestinal, lung or cervical cancer patients
  • performance status 0-1
  • age between 20 and 80
  • at least 4 weeks after previous therapy
  • life expectancy more than 3 months
  • permissible bone marrow, liver and renal function
  • HLA-A2402
  • no viral hepatitis, HIV or HTLV1

Exclusion criteria

  • severe underlying disease
  • pregnant or lactating women
  • active brain metastasis
  • uncontrollable infection
  • under systemic corticosteroid or immune suppressant treatment
  • history of allergy to epitope peptides or IFA

Treatment and study plan

5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

Biological

1mg each of 5 peptides with IFA. 4 weekly s.c. administration.

Other names: 5 peptide cocktail

Primary outcomes

  1. safety of the cyclophosphamide combined tumor specific epitope peptide cocktail

    Time frame: 2 years

Secondary outcomes

  1. immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

Kyushu University

Other

Collaborators

  • Human Genome Center, Institute of Medical Science, University of Tokyo

Registry information

Official study title

Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)

Acronym: peptidevac

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 13, 2008
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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