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Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
CDCA1
Sponsored by
Iwate Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring novel epitope peptide, CTL, advanced prostate cancer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Iwate Medical University School of Medicine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

objective response rate as assessed by RECIST criteria
measurement of PSA
CTL response
CD 8 population
change in level of regulatory T cells
PFS and OS

Full Information

First Posted
October 20, 2010
Last Updated
June 22, 2011
Sponsor
Iwate Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT01225471
Brief Title
Novel Peptide Vaccination for Patients With Advanced Prostate Cancer
Official Title
Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Iwate Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
novel epitope peptide, CTL, advanced prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
CDCA1
Intervention Description
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 Measure Information:
Title
feasibility (toxicities as assessed by NCI-CTCAE version 3)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
objective response rate as assessed by RECIST criteria
Time Frame
2 years
Title
measurement of PSA
Time Frame
2 years
Title
CTL response
Time Frame
2 years
Title
CD 8 population
Time Frame
2 years
Title
change in level of regulatory T cells
Time Frame
2 years
Title
PFS and OS
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DISEASE CHARACTERISTICS advanced prostate cancer which already showed resistance to standard treatments PATIENTS CHARACTERISTICS Patients who showed resistance to hormonal therapy and chemotherapy Histological diagnosis is adenocarcinoma HLA-A*2402 ECOG performance status of 0 to 2 Age ≥ 20 years, ≤85 years 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 life expectancy ≥ 2months Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breastfeeding Patients willing to childbearing ( Refusal or inability to use effective means of contraception) Serious infections requiring antibiotics Concomitant treatment with steroids or immunosuppressing agent Other malignancy difficult to control. Decision of unsuitableness by principal investigator or physician-in-charge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoaki Fujioka, MD, PhD
Organizational Affiliation
Department of Urology, Iwate Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Iwate Medical University School of Medicine
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28498618
Citation
Obara 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.
Results Reference
derived

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Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

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