Novel Peptide Vaccination for Patients With Advanced Bladder Cancer
NCT ID: NCT00635336
Last Updated: 2010-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2007-02-28
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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MPHOSPH1 and DEPDC1
DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. 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
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Inclusion Criteria
1. advanced bladder cancer which already showed resistance to standard treatments
2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor
PATIENTS CHARACTERISTICS
1. Patients who showed resistance to standard chemotherapies or radiotherapy
2. Histological diagnosis is transitional cell carcinoma
3. HLA-A\*2402
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. lesion of bladder cancer must express MPHOSPH1 or DEPDC1
8. Able and willing to give valid written informed consent
Exclusion Criteria
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
20 Years
80 Years
ALL
No
Sponsors
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Human Genome Center, Institute of Medical Science, University of Tokyo
OTHER
Iwate Medical University
OTHER
Responsible Party
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Iwate Medical University
Principal Investigators
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Tomoaki Fujioka, M.D. & Ph.D.
Role: STUDY_CHAIR
Department of Urology, Iwate Medical University
Locations
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Iwate Medical University School of Medicine
Morioka, Iwate, Japan
Countries
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References
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Rosenberg SA, Lotze MT, Yang JC, Aebersold PM, Linehan WM, Seipp CA, White DE. Experience with the use of high-dose interleukin-2 in the treatment of 652 cancer patients. Ann Surg. 1989 Oct;210(4):474-84; discussion 484-5. doi: 10.1097/00000658-198910000-00008.
Okabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37.
Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.
Bienz M, Clevers H. Linking colorectal cancer to Wnt signaling. Cell. 2000 Oct 13;103(2):311-20. doi: 10.1016/s0092-8674(00)00122-7. No abstract available.
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.
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.
Other Identifiers
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IMU-H18-59-P1
Identifier Type: -
Identifier Source: org_study_id