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Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01225471
Recruitment Status : Unknown
Verified June 2009 by Iwate Medical University.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2010
Last Update Posted : June 23, 2011
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: CDCA1 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer
Study Start Date : June 2009
Primary Completion Date : May 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Intervention Details:
    Biological: CDCA1
    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.

Primary Outcome Measures :
  1. feasibility (toxicities as assessed by NCI-CTCAE version 3) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. objective response rate as assessed by RECIST criteria [ Time Frame: 2 years ]
  2. measurement of PSA [ Time Frame: 2 years ]
  3. CTL response [ Time Frame: 2 years ]
  4. CD 8 population [ Time Frame: 2 years ]
  5. change in level of regulatory T cells [ Time Frame: 2 years ]
  6. PFS and OS [ Time Frame: 2 years ]

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

DISEASE CHARACTERISTICS advanced prostate cancer which already showed resistance to standard treatments


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225471

Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505
Sponsors and Collaborators
Iwate Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Tomoaki Fujioka, MD, PhD Department of Urology, Iwate Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Departmet of Urology, Iwate Medical University
ClinicalTrials.gov Identifier: NCT01225471     History of Changes
Other Study ID Numbers: IMU-H21-40-PⅠ/Ⅱ
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2009

Keywords provided by Iwate Medical University:
novel epitope peptide
advanced prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases