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

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by:

Kyushu University

ClinicalTrials.gov Identifier:

NCT00676949

First received: March 3, 2008

Last updated: June 22, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2008

Last Updated Date

June 22, 2011

Start Date ^ICMJE

November 2007

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

safety of the cyclophosphamide combined tumor specific epitope peptide cocktail [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00676949 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Tumors

Intervention ^ICMJE

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

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

Other Name: 5 peptide cocktail

Study Arm (s)

Experimental: 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.

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

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00676949

Other Study ID Numbers ^ICMJE

KU-CY5peptides, 19-40

Has Data Monitoring Committee

Yes

Responsible Party

Department of Advanced Molecular and Cell Therapy, Kyushu University

Study Sponsor ^ICMJE

Kyushu University

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Kenzaburo Tani, MD,phD

Medical Institute of Bioregulation, Kyushu University

Information Provided By

Kyushu University

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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