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

NCT ID: NCT00676949

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-03-31

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.

Conditions

Metastatic Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Interventions

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

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

Intervention Type: BIOLOGICAL

Other Intervention Names

5 peptide cocktail

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Kyushu University

OTHER

Sponsor Role: lead

Responsible Party

Kyushu University

Principal Investigators

Kenzaburo Tani, MD,phD

Role: PRINCIPAL_INVESTIGATOR

Medical Institute of Bioregulation, Kyushu University

Locations

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Countries

Japan

References

Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.

Reference Type: BACKGROUND

PMID: 15930316 (View on PubMed)

Other Identifiers

19-40

Identifier Type: OTHER

Identifier Source: secondary_id

KU-CY5peptides

Identifier Type: -

Identifier Source: org_study_id