UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1 study of HSP105-derived peptide vaccine for patients with advanced esophageal cancer/ colo- rectal cancer.
Title of the study (Brief title)	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	Takashi Kojima
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
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	Takashi Kojima
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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