UMIN-CTR Clinical Trial

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)
Email

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
Email	amiyazak@sapmed.ac.jp

Sponsor
Institute	Department of Oral Surgery, Sapporo Medical University School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001159