Novel Peptide Vaccination for Patients With Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase1/2 Study of Vaccination With CDCA1 Derived Epitope Peptide for HLA-A24-positive Patients With Advanced Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01225471
• Other study ID #: IMU-H21-40-P?/?
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 20, 2010
• Last updated: June 22, 2011
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2009
• Source: Iwate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Japan	Iwate Medical University School of Medicine	Morioka	Iwate

Sponsors (2)

Lead Sponsor	Collaborator
Iwate Medical University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility (toxicities as assessed by NCI-CTCAE version 3)		2 years	Yes
Secondary	objective response rate as assessed by RECIST criteria		2 years	Yes
Secondary	measurement of PSA		2 years	Yes
Secondary	CTL response		2 years	No
Secondary	CD 8 population		2 years	No
Secondary	change in level of regulatory T cells		2 years	No
Secondary	PFS and OS		2 years	No