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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
    • Time Frame: 2 years

Secondary Measures

  • immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
    • Time Frame: 2.5 years

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyushu University
  • Collaborator
    • Human Genome Center, Institute of Medical Science, University of Tokyo
  • Provider of Information About this Clinical Study
    • Department of Advanced Molecular and Cell Therapy, Kyushu University
  • Overall Official(s)
    • Kenzaburo Tani, MD,phD, Principal Investigator, Medical Institute of Bioregulation, Kyushu University

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.

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