Clinical trial NCT01225471: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: novel epitope peptide
CTL
advanced prostate cancer
Lead sponsor: Iwate Medical University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2010-10-21
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: feasibility (toxicities as assessed by NCI-CTCAE version 3)
timeFrame: 2 years
Secondary outcomes:
measure: objective response rate as assessed by RECIST criteria
timeFrame: 2 years
measure: measurement of PSA
timeFrame: 2 years
measure: CTL response
timeFrame: 2 years
measure: CD 8 population
timeFrame: 2 years
measure: change in level of regulatory T cells
timeFrame: 2 years
measure: PFS and OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Morioka
country: Japan
facility: Iwate Medical University School of Medicine
state: Iwate
Study officials:
affiliation: Department of Urology, Iwate Medical University
name: Tomoaki Fujioka, MD, PhD
role: STUDY_CHAIR
References:
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.