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Bladder CancerPhase 2NCT00633204

Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

A Phase 2 study testing MPHOSPH1 and DEPDC1 in people with Bladder Cancer, run by Iwate Medical University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Bladder Cancer
What is being tested?
MPHOSPH1 and DEPDC1
Type of treatment
Injection or infusion
How many people
150 participants
Where
1 siteJapan
Study dates
Feb 2008to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Iwate Medical University School of Medicine

    Morioka, Iwate, 020-8505

Other trials in Japan

About this study

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

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.

Conditions
Bladder Cancer
Being tested
MPHOSPH1 and DEPDC1
Keywords
Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination, Bladder cancer after surgery
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate after surgery (TUR-BT)

    Measured: 2 years

Secondary outcomes (5)

  1. feasibility

    Measured: 2 years

  2. CTL response

    Measured: 2 years

  3. CD8 population

    Measured: 2 years

  4. Change in level of regulatory T cells

    Measured: 2 years

  5. Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionNov 2011 (estimated)
  4. Study completionNov 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00633204
Sponsor's protocol ID
IMU-H18-59-P2
Status last verified
Jan 2009
First submitted
4 Mar 2008
Last updated
23 Jun 2011
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MPHOSPH1 and DEPDC1 in people with Bladder Cancer, run by Iwate Medical University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate after surgery (TUR-BT) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00633204, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.

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