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

Phase 1

Completed

• Conditions: Metastatic Tumors
• Interventions: Biological: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

• Registration Number: NCT00676949
• Lead Sponsor: Kyushu University

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-13
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1	cyclophosphamide dose escalation, level 1:150mg/m2,level 2: 300mg/m2, level 3: 300mg/m2x2, with 5 kinds o tumor specific antigen peptides followed by low dose IL-2, 6 patients will be enrolled for each level.

Primary Outcome Measures

Name	Time	Method
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan