NCT00633204

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

January 1, 2009

Enrollment Period

3.8 years

First QC Date

March 4, 2008

Last Update Submit

June 22, 2011

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate after surgery (TUR-BT)

    2 years

Secondary Outcomes (5)

  • feasibility

    2 years

  • CTL response

    2 years

  • CD8 population

    2 years

  • Change in level of regulatory T cells

    2 years

  • Overall survival

    5 years

Interventions

MPHOSPH1 and DEPDC1BIOLOGICAL

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.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Location

Related Publications (2)

  • 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.

    PMID: 17409436RESULT

  • 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.

    PMID: 17452976RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

KIF20B protein, humanDEPDC1 protein, human

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Tomoaki Fujioka, M.D. & Ph.D.

    Department of Urology, Iwate Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 11, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 23, 2011

Record last verified: 2009-01

Locations

JP(1)