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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004994 |
Receipt No. | R000005938 |
Scientific Title | Cancer specific vaccine therapy using HLA-A24 restricted epitope-peptide for patients with advanced metastatic colorectal cancer.PhaseI/II clinical trial. |
Date of disclosure of the study information | 2011/02/10 |
Last modified on | 2012/08/23 |
Basic information | ||
Public title | Cancer specific vaccine therapy using HLA-A24 restricted epitope-peptide for patients with advanced metastatic colorectal cancer.PhaseI/II clinical trial. | |
Acronym | Cancer peptide vaccine for advanced metastatic cancer. | |
Scientific Title | Cancer specific vaccine therapy using HLA-A24 restricted epitope-peptide for patients with advanced metastatic colorectal cancer.PhaseI/II clinical trial. | |
Scientific Title:Acronym | Cancer peptide vaccine for advanced metastatic cancer. | |
Region |
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Condition | |||
Condition | colorectal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To detemine the safety and responsiveness of peptide vaccines cocktail(FOXM1,MELK,HJURP) for HLA-A24 positive patients with advanced colorectal cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | Safety
Overall survival |
Key secondary outcomes | Immunological responce(in vitro CTL induction)
Responsiveness(tumor size) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Subctaneus injection of cancer peptide vaccine(three peptides) | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1 Standard therapies failured
2 Performance status 0-1 3 Lesions identifiable with images 4 More than 4 weeks after previous therapy 5 Prognosis no less than 3 months 6 WBC 2000 -15000, Platelet =>50000, GOT, GPT =<150, Cr =< 3.0 TB =< 3.0 7 HLA-A24 positive 8 Written informed consent |
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Key exclusion criteria | 1 Expectant
2 During lactation 3 possible expectant women 4 Active infectious diseases 5 Systemic use of steroid hormones or immunosuppressive drugs 6 Others (Doctors judges) |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido Cancer Center | ||||||
Division name | Gatroenterology | ||||||
Zip code | |||||||
Address | Sapporo City, Hokkaido | ||||||
TEL | 011-811-9111 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido Cancer Center | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Sapporo City, Hokkaido | ||||||
TEL | 011-811-9111 | ||||||
Homepage URL | |||||||
takahasi@sap-cc.go.jp |
Sponsor | |
Institute | Hokkaido Cancer Center |
Institute | |
Department |
Funding Source | |
Organization | Hokkaido Cancer Center |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | The Institute of Medical Science, The University of Tokyo |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北海道がんセンター(北海道) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005938 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |