UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017809
Receipt number 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 10:39:37

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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 or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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

Value
https://center6.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