Prostate Cancer
Conditions
Keywords
novel epitope peptide, CTL, advanced prostate cancer
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.
Interventions
BIOLOGICALCDCA1
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.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Iwate Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility (toxicities as assessed by NCI-CTCAE version 3) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| measurement of PSA | 2 years |
| CTL response | 2 years |
| objective response rate as assessed by RECIST criteria | 2 years |
| change in level of regulatory T cells | 2 years |
| PFS and OS | 2 years |
| CD 8 population | 2 years |
Countries
Japan
Outcome results
None listed