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Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Iwate Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University
ClinicalTrials.gov Identifier:
NCT01225471
First received: October 20, 2010
Last updated: June 22, 2011
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Prostate Cancer
 Biological: CDCA1
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Iwate Medical University:

Primary Outcome Measures:
  • feasibility (toxicities as assessed by NCI-CTCAE version 3) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • objective response rate as assessed by RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • measurement of PSA [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • CTL response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • CD 8 population [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • change in level of regulatory T cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • PFS and OS [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225471

Locations
Japan
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
Investigators
Study Chair: Tomoaki Fujioka, MD, PhD Department of Urology, Iwate Medical University
  More Information

No publications provided

Responsible Party: Departmet of Urology, Iwate Medical University
ClinicalTrials.gov Identifier: NCT01225471     History of Changes
Other Study ID Numbers: IMU-H21-40-PⅠ/Ⅱ
Study First Received: October 20, 2010
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 22, 2013