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Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

Sponsor
Iwate Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01225471
Collaborator
Human Genome Center, Institute of Medical Science, University of Tokyo (Other)
30
Enrollment
1
Location
35
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • 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-A2402 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-A2402. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
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 :
Jun 1, 2009
Actual Primary Completion Date :
May 1, 2011
Anticipated Study Completion Date :
May 1, 2012

Outcome Measures

Primary Outcome Measures

  1. feasibility (toxicities as assessed by NCI-CTCAE version 3) [2 years]

Secondary Outcome Measures

  1. objective response rate as assessed by RECIST criteria [2 years]

  2. measurement of PSA [2 years]

  3. CTL response [2 years]

  4. CD 8 population [2 years]

  5. change in level of regulatory T cells [2 years]

  6. PFS and OS [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01225471
Other Study ID Numbers:
  • IMU-H21-40-PⅠ/Ⅱ
First Posted:
Oct 21, 2010
Last Update Posted:
Jun 23, 2011
Last Verified:
Jun 1, 2009
Keywords provided by , ,
novel epitope peptide
CTL
advanced prostate cancer
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jun 23, 2011