Clinical trial · Interventional
Novel Peptide Vaccination for Patients With Advanced Prostate Cancer
Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer
NCT01225471CI-TRIAL-00005067unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide vaccination for advanced prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDCA1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- feasibility (toxicities as assessed by NCI-CTCAE version 3)
- timeFrame
- 2 years
Secondary outcomes (6)
- measure
- objective response rate as assessed by RECIST criteria
- timeFrame
- 2 years
- measure
- measurement of PSA
- timeFrame
- 2 years
- measure
- CTL response
- timeFrame
- 2 years
- measure
- CD 8 population
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDObara W, Sato F, Takeda K, Kato R, Kato Y, Kanehira M, Takata R, Mimata H, Sugai T, Nakamura Y, Fujioka T. Phase I clinical trial of cell division associated 1 (CDCA1) peptide vaccination for castration resistant prostate cancer. Cancer Sci. 2017 Jul;108(7):1452-1457. doi: 10.1111/cas.13278. Epub 2017 Jun 23. PMID 28498618