UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000999 |
|---|---|
| Receipt number | R000001159 |
| Scientific Title | Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA and IFN-alpha for Patients with Oral Cancer (Phase I clinical study) |
| Date of disclosure of the study information | 2008/01/28 |
| Last modified on | 2021/02/14 11:36:50 |
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Basic information
Public title
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA and IFN-alpha for Patients with Oral Cancer (Phase I clinical study)
Acronym
Phase I Clinical Study of Survivin-2B Peptide Vaccine Therapy Mixed with IFA and IFN -alpha
Scientific Title
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA and IFN-alpha for Patients with Oral Cancer (Phase I clinical study)
Scientific Title:Acronym
Phase I Clinical Study of Survivin-2B Peptide Vaccine Therapy Mixed with IFA and IFN -alpha
Region
| Japan |
Condition
Condition
Advanced or recurrent oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and efficacy of survivin-2B peptide mixed with IFA and IFN-alpha.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Toxicity
Key secondary outcomes
Clinical and immunological responses. Clinical responses are evaluated by RECIST criteria and change of tumor marker levels. Immunological responses are evaluated by DTH, tetramer staining and ELISPOT assay.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Vaccination of survivin-2B peptide 1.0mg mixed with IFA every 2 weeks, and IFN-alpha 1,500,000 IU twice a week.
Interventions/Control_2
Vaccination of survivin-2B peptide 1.0mg mixed with IFA every 2 weeks, and IFN-alpha 3,000,000 IU twice a week.
Interventions/Control_3
Vaccination of survivin-2B peptide 1.0mg mixed with IFA every 2 weeks, and PEG-IFN-alpha-2a 90ug once a week.
Interventions/Control_4
Vaccination of survivin-2B peptide 1.0mg mixed with IFA every 2 weeks, and PEG-IFN-alpha-2a 180ug once a week.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven oral cancer, 2) HLA class I-positive and survivin-positive in the cancerous lesions by immunohistochemistry, 3) HLA-A*2402 positive, 4) unresectable advanced or recurrent oral cancer, 5) from 20-90 years old, 6) ECOG performance status between 0 and 3.
Key exclusion criteria
1) prior cancer therapy, such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, 2) presence of other cancers that might influence the prognosis, 3) immunodeficiency or a history of splenectomy, 4) severe cadiac insufficiency, acute infection, or hematopoietic failure, 5) ongoing brest-feeding, 6) unsuitability for the trial based on clinical judgement.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Miyazaki |
Organization
Sapporo Medical University
Division name
Department of Oral Surgery
Zip code
Address
South-1, West-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111(ext.3578)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Miyazaki |
Organization
Sapporo Medical University
Division name
Department of Oral Surgery
Zip code
Address
South-1, West-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111(ext.3578)
Homepage URL
amiyazak@sapmed.ac.jp
Sponsor or person
Institute
Department of Oral Surgery, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Corporation Innovation Plaza Hokkaido, Sapporo, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Pathology, Sapporo Medical University School of Medicine
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
| 2008 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
| 2006 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2006 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001159
