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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00676949

Acronym

peptidevac

Enrollment

Registered

2008-05-13

Start date

2007-11-30

Completion date

2010-03-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Tumors

Keywords

epitope peptide, cyclophosphamide, interleukin-2

Brief summary

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

Detailed description

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.

Interventions

BIOLOGICAL5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail	2 years

Secondary

Measure	Time frame
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail	2.5 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026