Status:
COMPLETED
Novel Peptide Vaccination for Patients With Advanced 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:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.
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. We have...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- advanced bladder cancer which already showed resistance to standard treatments
- Protein expression of MPHOSPH1 and DEPDC1 on the tumor
- PATIENTS CHARACTERISTICS
- Patients who showed resistance to standard chemotherapies or radiotherapy
- Histological diagnosis is transitional cell carcinoma
- HLA-A\*2402
- 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
- lesion of bladder cancer must express MPHOSPH1 or DEPDC1
- Able and willing to give valid written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00635336
Start Date
February 1 2007
End Date
February 1 2010
Last Update
October 21 2010
Active Locations (1)
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1
Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505