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

Kyushu University18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Tumors

Interventions

5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Outcomes

Primary Outcomes

safety of the cyclophosphamide combined tumor specific epitope peptide cocktail

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2.5 years

Data from ClinicalTrials.gov

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