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

Kyushu University

Status and phase: Completed; Phase 1

Conditions: Metastatic Tumors

Treatments: Biological: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

Study type: Interventional

Funder types: Other

Identifiers

NCT00676949

KU-CY5peptides

19-40 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

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