UMIN-CTR Clinical Trial

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

advanced esophageal cancer/ colo- rectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

P1a:Proportion of dose limiting toxicity
P1b:Response rate

Key secondary outcomes

Progression free survival
Treatment failure rate
Adverse events
Immunological effects

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Early/exploratory clinical research center

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2015

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

06

Month

04

Day

Last modified on

2017

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020476