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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001599 |
Receipt No. | R000001877 |
Scientific Title | CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer |
Date of disclosure of the study information | 2008/12/25 |
Last modified on | 2018/12/18 |
Basic information | ||
Public title | CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer | |
Acronym | CHP-MAGE-A4 vaccine study | |
Scientific Title | CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer | |
Scientific Title:Acronym | CHP-MAGE-A4 vaccine study | |
Region |
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Condition | ||||||||||||
Condition | MAGE-A4-expressing therapy-resistant cancer (non origin-limited) | |||||||||||
Classification by specialty |
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Classification by malignancy | Malignancy | |||||||||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To see maximum-tolerable dose and give biological recommended dose by evaluating safety profiles and immune responses with repeated doses of CHP-MAGE-A4 vaccine in a dose-escalating study of 100 or 300 microgram. |
Basic objectives2 | Others |
Basic objectives -Others | To evaulate tumor response, progression-free time, overall survival, response-duration time and time-to-progression |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | Safety:maximum-tolerable dose, dose-limting toxicity, profiles of adverse events.
Efficacy: MAGE-A4-specific immune responses |
Key secondary outcomes | Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression |
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 | Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram or 300 microgram,every two weeks, repeated at least six cycles | ||
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.MAGE-A4-expressing therapy-resistant cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk if reccurrence.
2.histoligically confirmed malignant tumor 3.MAGE-A4-antigen expressing. 4.Performance status(ECOG) 0 to 2. 5.Aged twenty or more, male or female 6.At least four-month life expectancy 7.Normal major organ function, and meeting the criteria below White cell counts 2,000/uL or more. Hemoglobin 8.0 g/dl or more. Platelets 75,000/uL or more. Serum bilirubin: within 1.5 times of normal upper level(within 3 times in case of liver damage). AST(GOT)/ALT(GPT): within 2.5 times of normal upper level(within 5 times in case of liver damage). Serum creatinine within 1.5 times of normal upper level. 8.Not willing to be pregnant (both sexes) 9.Having written informed consent. |
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Key exclusion criteria | 1.HIV-positives.
2.Double cancers. 3.Autoimmune disease. 4.History of serious hypersensitivity. 5.Active CNS metastasis. 6.Lasting less than four weeks from the previous chemotherapy, systemic corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to primary tumors 7.Pregnant or lactating. 8.Inappropriate for study entry judged by an attending physician. |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Mie University Graduate School of Medicine | ||||||
Division name | Immuno-Gene Therapy | ||||||
Zip code | |||||||
Address | 2-174, Edobashi, Tsu, Mie, 514-8507 Japan | ||||||
TEL | 059-231-5187 | ||||||
kageyama@clin.medic.mie-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | CHP-MAGE-A4 clinical trial registry | ||||||
Division name | Cancer vaccine, Mie Universituy | ||||||
Zip code | |||||||
Address | 2-174, Edobashi, Tsu, Mie, 514-8507 Japan | ||||||
TEL | 059-231-5280 | ||||||
Homepage URL | |||||||
kageyama@clin.medic.mie-u.ac.jp |
Sponsor | |
Institute | CHP-MAGE-A4 cancer vaccine study at Mie University |
Institute | |
Department |
Funding Source | |
Organization | Mie University Graduate School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.oncotarget.com/index.php?journal=oncotarget&page=article&op=view&path%5B%5D=26323&path%5B |
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 |
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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=R000001877 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |