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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Tumors

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 1mg each of 5 peptides with IFA. 4 weekly s.c. administration.<br>* Other names: 5 peptide cocktail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of the cyclophosphamide combined tumor specific epitope peptide cocktail |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail |  | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epitope peptide, cyclophosphamide, interleukin-2