UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008006 |
|---|---|
| Receipt number | R000009416 |
| Scientific Title | Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid tumor. |
| Date of disclosure of the study information | 2012/05/21 |
| Last modified on | 2018/01/12 18:00:24 |
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Basic information
Public title
Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid tumor.
Acronym
Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid Tumor.
Scientific Title
Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid tumor.
Scientific Title:Acronym
Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid Tumor.
Region
| Japan |
Condition
Condition
Refractory Solid Tumor
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the adverse effect and immune response in patients with NY-ESO-1-expressing refractory solid tumor treated long-term with the CHP-NY-ESO-1 cancer vaccine and the immunological adjuvant MIS416.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse effects.
Key secondary outcomes
Immune response, QOL, and the change in serum PSA (prostate cancer only).
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
| Vaccine |
Interventions/Control_1
CHP-NY-ESO-1, MIS416
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Completion of the study 'Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Urothelial or Prostate Cancer' or 'Phase I Study on the Combination Therapy of IMF-001 and MIS416 for the Treatment of Patients with NY-ESO-1-expressing malignant solid tumor'.
2) Non-progressive disease on the study termination image test of 'Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Urothelial or Prostate Cancer' or 'Phase I Study on the Combination Therapy of IMF-001 and MIS416 for the Treatment of Patients with NY-ESO-1-expressing malignant solid tumor'.
3) Cooperativeness to written informed consent must be obtained and documented.
Key exclusion criteria
None
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sugimura |
Organization
Mie University Graduate School of Medicine
Division name
Dep. of Nephro-Urologic Surgery and Andrology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Mie University Graduate School of Medicine
Division name
Dep. of Cancer Vaccine / Immuno-Gene Therapy Study Secretariat
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5684
Homepage URL
http://www.shikuken.jp/
cv-adm@doc.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Foundation
Organization
Division
Category of Funding Organization
Outside Japan
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
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 21 | Day |
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
| 2010 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
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
| 2012 | Year | 05 | Month | 21 | Day |
Last modified on
| 2018 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009416
