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Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

Primary Purpose

Bladder Cancer

Status

Unknown status

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

MPHOSPH1 and DEPDC1

About this trial

This is an interventional prevention trial for Bladder Cancer focused on measuring Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination, Bladder cancer after surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria DISEASE CHARACTERISTICS

Bladder cancer without solitary and low grade tumor
Protein expression of MPHOSPH1 and DEPDC1 on the tumor

PATIENTS CHARACTERISTICS

Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt.
Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder.
Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy
ECOG performance status of 0 to 1
Age ≥ 20 years, ≤80 years
WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl
Samples of bladder cancer must express MPHOSPH1 or DEPDC1
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

Sites / Locations

Iwate Medical University School of Medicine

Outcomes

Primary Outcome Measures

Recurrence rate after surgery (TUR-BT)

Secondary Outcome Measures

feasibility

CTL response

CD8 population

Change in level of regulatory T cells

Overall survival

Full Information

NCT ID

NCT00633204

First Posted

March 4, 2008

Last Updated

June 22, 2011

Sponsor

Iwate Medical University

Collaborators

Human Genome Center, Institute of Medical Science, University of Tokyo

1. Study Identification

Unique Protocol Identification Number

NCT00633204

Brief Title

Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

Official Title

Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

November 2011 (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 clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt

Detailed Description

DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. The investigators have determined the HLA-A*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the prevention of the recurrence of the bladder cancer after surgery using these peptides.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination, Bladder cancer after surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

MPHOSPH1 and DEPDC1

Intervention Description

DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week after curative surgery 8 times and BCG in bladder simultaneously. Then, DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered once every month. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.

Primary Outcome Measure Information:

Title

Recurrence rate after surgery (TUR-BT)

Time Frame

2 years

Secondary Outcome Measure Information:

Title

feasibility

Time Frame

2 years

Title

CTL response

Time Frame

2 years

Title

CD8 population

Time Frame

2 years

Title

Change in level of regulatory T cells

Time Frame

2 years

Title

Overall survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria DISEASE CHARACTERISTICS Bladder cancer without solitary and low grade tumor Protein expression of MPHOSPH1 and DEPDC1 on the tumor PATIENTS CHARACTERISTICS Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt. Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder. Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy ECOG performance status of 0 to 1 Age ≥ 20 years, ≤80 years WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl Samples of bladder cancer must express MPHOSPH1 or DEPDC1 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, M.D. & Ph.D.

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

17409436

Citation

Kanehira M, Katagiri T, Shimo A, Takata R, Shuin T, Miki T, Fujioka T, Nakamura Y. Oncogenic role of MPHOSPH1, a cancer-testis antigen specific to human bladder cancer. Cancer Res. 2007 Apr 1;67(7):3276-85. doi: 10.1158/0008-5472.CAN-06-3748.

Results Reference

result

PubMed Identifier

17452976

Citation

Kanehira M, Harada Y, Takata R, Shuin T, Miki T, Fujioka T, Nakamura Y, Katagiri T. Involvement of upregulation of DEPDC1 (DEP domain containing 1) in bladder carcinogenesis. Oncogene. 2007 Sep 27;26(44):6448-55. doi: 10.1038/sj.onc.1210466. Epub 2007 Apr 23.

Results Reference

result

Learn more about this trial

Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

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