UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000905 |
|---|---|
| Receipt number | 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 10:08:33 |
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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
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
iwayama@sapmed.ac.jp
Sponsor or person
Institute
Department of 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001086
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