Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

Phase 1

• Conditions: Prostate Cancer

• Registration Number: NCT01225471
• Lead Sponsor: Iwate Medical University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Primary Completion: 2011-05
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

DISEASE CHARACTERISTICS advanced prostate cancer which already showed resistance to standard treatments

PATIENTS CHARACTERISTICS

1. Patients who showed resistance to hormonal therapy and chemotherapy
2. Histological diagnosis is adenocarcinoma
3. HLA-A*2402
4. ECOG performance status of 0 to 2
5. Age ≥ 20 years, ≤85 years
6. 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
7. life expectancy ≥ 2months
8. Able and willing to give valid written informed consent

Exclusion Criteria

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Other malignancy difficult to control.
7. Decision of unsuitableness by principal investigator or physician-in-charge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility (toxicities as assessed by NCI-CTCAE version 3)	2 years

Secondary Outcome Measures

Name	Time	Method
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
objective response rate as assessed by RECIST criteria	2 years

Trial Locations

Locations (1)

Iwate Medical University School of Medicine; 🇯🇵 Morioka, Iwate, Japan