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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

March 3, 2008
June 22, 2011
November 2007
March 2010   (final data collection date for primary outcome measure)
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00676949 on ClinicalTrials.gov Archive Site
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Tumors
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
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
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.
 
Completed
18
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00676949
KU-CY5peptides, 19-40
Yes
Department of Advanced Molecular and Cell Therapy, Kyushu University
Kyushu University
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Kenzaburo Tani, MD,phD Medical Institute of Bioregulation, Kyushu University
Kyushu University
April 2011

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