Status:
UNKNOWN
Novel Peptide Vaccination for Patients With Advanced Prostate Cancer
Lead Sponsor:
Iwate Medical University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Prostate Cancer
Eligibility:
MALE
20-85 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01225471
Start Date
June 1 2009
End Date
May 1 2012
Last Update
June 23 2011
Active Locations (1)
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1
Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505