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

Metastatic Tumors Clinical Trial

— peptidevac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676949
• Other study ID #: KU-CY5peptides
• Secondary ID: 19-40
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2008
• Last updated: June 22, 2011
• Start date: November 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: Kyushu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Metastatic Tumors
• Neoplasm Metastasis

Intervention

Biological:
• 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
1mg each of 5 peptides with IFA. 4 weekly s.c. administration.

Locations

Country	Name	City	State
Japan	Kyushu University Hospital	Fukuoka

Sponsors (2)

Lead Sponsor	Collaborator
Kyushu University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of the cyclophosphamide combined tumor specific epitope peptide cocktail		2 years	Yes
Secondary	immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail		2.5 years	Yes

External Links

•   Department of Advanced Molecular and Cell Therapy