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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
History of Changes
  Purpose

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


Condition Intervention Phase
Metastatic Tumors
 Biological: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyushu University:

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

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

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676949

Locations
Japan
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Sponsors and Collaborators
Kyushu University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Principal Investigator: Kenzaburo Tani, MD,phD Medical Institute of Bioregulation, Kyushu University
  More Information

Additional Information:
Department of Advanced Molecular and Cell Therapy  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Department of Advanced Molecular and Cell Therapy, Kyushu University
ClinicalTrials.gov Identifier: NCT00676949     History of Changes
Other Study ID Numbers: KU-CY5peptides, 19-40
Study First Received: March 3, 2008
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyushu University:
epitope peptide
cyclophosphamide
interleukin-2

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on June 18, 2013