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Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer


Phase 1/Phase 2
20 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility (toxicities as assessed by NCI-CTCAE version 3)

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Tomoaki Fujioka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Urology, Iwate Medical University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

IMU-H21-40-PⅠ/Ⅱ

NCT ID:

NCT01225471

Start Date:

June 2009

Completion Date:

May 2012

Related Keywords:

  • Prostate Cancer
  • novel epitope peptide
  • CTL
  • advanced prostate cancer
  • Prostatic Neoplasms

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