Novel Peptide Vaccination for Patients With Advanced Prostate Cancer
Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide vaccination for advanced prostate cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 20, 2010
CompletedFirst Posted
Study publicly available on registry
October 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 23, 2011
June 1, 2009
1.9 years
October 20, 2010
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
feasibility (toxicities as assessed by NCI-CTCAE version 3)
2 years
Secondary Outcomes (6)
objective response rate as assessed by RECIST criteria
2 years
measurement of PSA
2 years
CTL response
2 years
CD 8 population
2 years
change in level of regulatory T cells
2 years
- +1 more secondary outcomes
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iwate Medical University School of Medicine
Morioka, Iwate, 020-8505, Japan
Related Publications (1)
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.
PMID: 28498618DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tomoaki Fujioka, MD, PhD
Department of Urology, Iwate Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 20, 2010
First Posted
October 21, 2010
Study Start
June 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2012
Last Updated
June 23, 2011
Record last verified: 2009-06