Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-26 @ 8:19 PM
Study NCT ID:
NCT00633204
Status:
UNKNOWN
Last Update Posted:
2011-06-23
First Post:
2008-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C438388', 'term': 'KIF20B protein, human'}, {'id': 'C584411', 'term': 'DEPDC1 protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-03-04', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate after surgery (TUR-BT)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'feasibility', 'timeFrame': '2 years'}, {'measure': 'CTL response', 'timeFrame': '2 years'}, {'measure': 'CD8 population', 'timeFrame': '2 years'}, {'measure': 'Change in level of regulatory T cells', 'timeFrame': '2 years'}, {'measure': 'Overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination', 'Bladder cancer after surgery'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '17409436', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '17452976', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria DISEASE CHARACTERISTICS\n\n1. Bladder cancer without solitary and low grade tumor\n2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor\n\nPATIENTS CHARACTERISTICS\n\n1. Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt.\n2. Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder.\n3. Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy\n4. ECOG performance status of 0 to 1\n5. Age ≥ 20 years, ≤80 years\n6. 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\n7. Samples of bladder cancer must express MPHOSPH1 or DEPDC1\n8. Able and willing to give valid written informed consent\n\nExclusion Criteria:\n\n1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)\n2. Breastfeeding\n3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)\n4. Serious infections requiring antibiotics\n5. Concomitant treatment with steroids or immunosuppressing agent\n6. Other malignancy difficult to control.\n7. Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT00633204', 'briefTitle': 'Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Iwate Medical University'}, 'officialTitle': 'Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt', 'orgStudyIdInfo': {'id': 'IMU-H18-59-P2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MPHOSPH1 and DEPDC1', 'type': 'BIOLOGICAL', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '020-8505', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University School of Medicine', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}], 'overallOfficials': [{'name': 'Tomoaki Fujioka, M.D. & Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Urology, Iwate Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iwate Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Genome Center, Institute of Medical Science, University of Tokyo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Department of Urology', 'oldOrganization': 'Iwate Medical University'}}}}