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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017809
Receipt No. R000020476
Scientific Title Phase 1 study of HSP105-derived peptide vaccine for patients with advanced esophageal cancer/ colo- rectal cancer.
Date of disclosure of the study information 2015/06/22
Last modified on 2017/08/25

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Basic information
Public title Phase 1 study of HSP105-derived peptide vaccine for patients with advanced esophageal cancer/ colo- rectal cancer.
Acronym HSP105 Phase I
Scientific Title Phase 1 study of HSP105-derived peptide vaccine for patients with advanced esophageal cancer/ colo- rectal cancer.
Scientific Title:Acronym HSP105 Phase I
Region
Japan

Condition
Condition advanced esophageal cancer/ colo- rectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 o determine a recommend dose and to evaluate the safety and efficacy of HSP105-derived peptide vaccine for patients with advanced esophageal cancer/ colo- rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes P1a:Proportion of dose limiting toxicity
P1b:Response rate
Key secondary outcomes Progression free survival
Treatment failure rate
Adverse events
Immunological effects

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 HSP105-derived peptide vaccine is administered weekly by intradermal injection, for a maximum of 1 year.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma of esophagus/adenocarcinoma of colon or rectum
2) Prior chemotherapy was discontinued due to disease progression, or an adverse event.
3) >=20 years old, <=75 years old
4) ECOG Performance Status of 0 or 1
5) With measurable disease according to RECIST ver 1.1.
6) Adequate organ function within 14 days prior to enrollment.
a. Hemoglobin >=8.0 g/dL
b. Absolute neutrophil >=1,500/mm3
c. Platelet >=75,000/mm3
d Total bilirubin <=1.5 mg/dL
e. AST <=100 U/L (with liver metastasis, AST <=200U/L)
f. ALT <=100 U/L (with liver metastasis, ALT <=200U/L)
g. Serum creatinine <=1.5mg/dL
7) Blood transfusion not within 14 days prior to enrollment.
8) Positive one either or more of HLA-A*24:02, 02:01, 02:06 , 02:07.
9) Recovered AEs related to prior treatment are Grade >= 1 according to CTCAE. (excluded alopecia, peripheral sensory neuropathy, skin hyperpigmentation, and dysgeusia)
10) Women of childbearing potential must have a negative pregnancy test within 14 days prior to enrollment.
11) Written informed consent
Key exclusion criteria 1) Pleural effusion or ascites required invasive treatment.
2) Chemotherapy within 4 weeks prior to enrollment.
3) Active infection requires systemic therapy.
4) Any severe medical conditions.
5) Historical or coexisting severe interstitial pneumonia.
6) Severe psychiatric disorder.
7) Women during pregnancy or lactation ,
8) Known serious drug allergy.
9) Positive HBs antigen or HCV antibody or HIV antibody within 6 months prior to enrollment.
10) Received the continuous whole body dosage (oral or intravenous) with steroid and other immunosuppressive drugs.
11) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kojima
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email takojima@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kojima
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email takojima@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Early/exploratory clinical research center

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 国立がん研究センター東病院(千葉県)、神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 22 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
2015 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 08 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
2015 Year 06 Month 04 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020476

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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