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Recruitment status
Unique ID issued by UMIN UMIN000000905
Receipt No. R000001086
Scientific Title Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA, IFA and IFN-alpha, IFA and IL-2, or IFA and GM-CSF for Patients with Digestive Cancer and Endocrine Organic Cancer (Phase I clinical study)
Date of disclosure of the study information 2007/11/23
Last modified on 2007/11/24

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Basic information
Public title Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA, IFA and IFN-alpha, IFA and IL-2, or IFA and GM-CSF for Patients with Digestive Cancer and Endocrine Organic Cancer (Phase I clinical study)
Acronym Phase I Clinical Study of Peptide Vaccine Therapy Using Survivin-2B peptide mixed with adjuvant
Scientific Title Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA, IFA and IFN-alpha, IFA and IL-2, or IFA and GM-CSF for Patients with Digestive Cancer and Endocrine Organic Cancer (Phase I clinical study)
Scientific Title:Acronym Phase I Clinical Study of Peptide Vaccine Therapy Using Survivin-2B peptide mixed with adjuvant
Region
Japan

Condition
Condition Advanced or recurrent digestive cancer and Endocrine Organic Cancer
Classification by specialty
Gastrointestinal surgery Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and investigation of anti-tumor effect of survivin-2B peptide mixed with IFA, IFA and IFN-alpha, IFA and IL-2, or IFA and GM-CSF.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Evaluation of adverse effect
Key secondary outcomes Evaluation of immunological and clinical responses. Immunological responses were investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses were evaluated by RECIST criteria and change of tumor marker levels.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Vaccination of survivin-2B peptide mixed with IFA every 2 weeks
Interventions/Control_2 Vaccination of survivin-2B peptide mixed with IFA every 2 weeks, and IFN-alpha twice a week
Interventions/Control_3 Vaccination of survivin-2B peptide mixed with IFA every 2 weeks, and IL-2 twice a week
Interventions/Control_4 Vaccination of survivin-2B peptide mixed with IFA every 2 weeks, and GM-CSF twice 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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients enrolled in this study were required to conform to the following criteria: (1) to have histologically confirmed digestive cancer and endocrine organic cancer, (2) to be HLA-A*2402 positive, (3) to be survivin-positive in the carcinomatous lesions by immunohistochemistry, (4) to be between 20 and 85 years old, (5) to be unresectable advanced cancer or recurrent cancer, (6) to have Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2.
Key exclusion criteria Exclusion criteria included (1) the presence of other cancers that might influence the prognosis, (2) immunodeficiency or a history of splenectomy, (3) need of steroid therapy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure, (5) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, (6) ongoing breast-feeding, and (7) unsuitability for the trial based on clinical judgment.
Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Iwayama
Organization Sapporo Medical University
Division name Department of Surgery
Zip code
Address South-1, West-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Iwayama
Organization Sapporo Medical University
Division name Department of Surgery
Zip code
Address South-1, West-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111(3281)
Homepage URL
Email iwayama@sapmed.ac.jp

Sponsor
Institute Department of 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
2007 Year 11 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

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
Date of protocol fixation
2004 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2004 Year 02 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 11 Month 23 Day
Last modified on
2007 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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