This trial is active, not recruiting.

Condition prostate cancer
Treatment cdca1
Phase phase 1/phase 2
Sponsor Iwate Medical University
Collaborator Human Genome Center, Institute of Medical Science, University of Tokyo
Start date June 2009
End date May 2011
Trial size 30 participants
Trial identifier NCT01225471, IMU-H21-40-PⅠ/Ⅱ


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

feasibility (toxicities as assessed by NCI-CTCAE version 3)
time frame: 2 years

Secondary Outcomes

objective response rate as assessed by RECIST criteria
time frame: 2 years
measurement of PSA
time frame: 2 years
CTL response
time frame: 2 years
CD 8 population
time frame: 2 years
change in level of regulatory T cells
time frame: 2 years
PFS and OS
time frame: 2 years

Eligibility Criteria

Male participants from 20 years up to 85 years old.

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

Additional Information

Official title Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Iwate Medical University.