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Status unknownNCT00633204Updated Jun 23, 2011

Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

A Phase 2 interventional study of MPHOSPH1 and DEPDC1 in Bladder Cancer, sponsored by Iwate Medical University. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Iwate Medical University · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt

Read the 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.

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Conditions studied

  • Bladder Cancer

Keywords

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

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Iwate Medical University is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

PATIENTS CHARACTERISTICS

  1. Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt.
  2. Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder.
  3. Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy
  4. ECOG performance status of 0 to 1
  5. Age ≥ 20 years, ≤80 years
  6. 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
  7. Samples of bladder cancer must express MPHOSPH1 or DEPDC1
  8. Able and willing to give valid written informed consent

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Interventions

  • BiologicalMPHOSPH1 and DEPDC1

    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.

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What researchers measure

Primary outcomes

  1. Recurrence rate after surgery (TUR-BT)

    Time frame: 2 years

Secondary outcomes

  1. feasibility

    Time frame: 2 years

  2. CTL response

    Time frame: 2 years

  3. CD8 population

    Time frame: 2 years

  4. Change in level of regulatory T cells

    Time frame: 2 years

  5. Overall survival

    Time frame: 5 years

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Study locations

1 site
  • Iwate Medical University School of Medicine
    Morioka, Iwate 020-8505, Japan
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References and documents

Publications

  • 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. PubMed 17409436 ↗
  • 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. PubMed 17452976 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00633204
Lead sponsor
Iwate Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
First posted
Mar 11, 2008
Start date
Feb 2008
Primary completion
Nov 2011 (estimated)
Completion
Nov 2011 (estimated)
Last update
Jun 23, 2011

Study contacts

Tomoaki Fujioka, M.D. & Ph.D.
study chair · Department of Urology, Iwate Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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