Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide vaccination for advanced prostate cancer

Detailed Description
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Cell division cycle associated gene 1(CDCA1) has been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. We have determined the HLA-A*2402 restricted epitope peptides derived from CDCA1, CDCA1-A24-56. This epitope showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A*2402. Furthermore, when vaccinated this peptide, specific CTL was determined after the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the advanced prostate cancer patients who already showed resistance to standard hormonal therapy and chemotherapy.

Official Title
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Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: CDCA1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DISEASE CHARACTERISTICS advanced prostate cancer which already showed resistance to standard treatments PATIENTS CHARACTERISTICS Patients who showed resistance to hormonal therapy and chemotherapy Histological diagnosis is adenocarcinoma HLA-A*2402 ECOG performance status of 0 to 2 Age ≥ 20 years, ≤85 years WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg life expectancy ≥ 2months Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breastfeeding Patients willing to childbearing ( Refusal or inability to use effective means of contraception) Serious infections requiring antibiotics Concomitant treatment with steroids or immunosuppressing agent Other malignancy difficult to control. Decision of unsuitableness by principal investigator or physician-in-charge

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

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

| Intervention/Treatment |
| --- |
|Biological: CDCA1|CDCA1-A24-56 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. This peptide conjugated with Montanide ISA 51 as an adjuvant.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility (toxicities as assessed by NCI-CTCAE version 3) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate as assessed by RECIST criteria |  | 2 years | 
| measurement of PSA |  | 2 years | 
| CTL response |  | 2 years | 
| CD 8 population |  | 2 years | 
| change in level of regulatory T cells |  | 2 years | 
| PFS and OS |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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novel epitope peptide, CTL, advanced prostate cancer