Status:
UNKNOWN
Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer
Lead Sponsor:
Iwate Medical University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Bladder Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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 inv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00633204
Start Date
February 1 2008
End Date
November 1 2011
Last Update
June 23 2011
Active Locations (1)
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1
Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505