UMIN-CTR Clinical Trial

Public title

Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with NY-ESO-1 expressing refractory esophageal cancer

Acronym

Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with refractory esophageal cancer

Scientific Title

Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with NY-ESO-1 expressing refractory esophageal cancer

Scientific Title:Acronym

Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with refractory esophageal cancer

Region

Japan

Condition

Refractory esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety, tolerability and immune response in NY-ESO-1-expressing refractory esophageal cancer patients treated with the CHP-NY-ESO-1 cancer vaccine and the immunological adjuvant Poly-ICLC

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Maximum tolerated dose (MTD), dose limiting toxicity (DLT) and adverse effects.

Key secondary outcomes

Immune response

Study type

Interventional

Basic design

expanded access

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

Medicine

Vaccine

Interventions/Control_1

First cohort
CHP-NY-ESO-1 200 micrograms
Poly-ICLC 0.5mg
SQ injection, q2wks, 6 cycles
Second cohort
CHP-NY-ESO-1 200 micrograms
Poly-ICLC 1.0mg
SQ injection, q2wks, 6 cycles
Third cohort
CHP-NY-ESO-1 200 micrograms
Poly-ICLC 2.0mg
SQ injection, q2wks, 6 cycles

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Standard therapy-resistant esophageal cancer with clinical stage IV or recurrent, metastatic disease.
2. Histologically confirmed esophageal cancer
3. NY-ESO-1-antigen expression of tumor confirmed by immunohistochemistry or RT-PCR
4. Life expectancy: >= 3 months from the date of consent
5. Age: >= 20 years
6. Performance status (ECOG scale): 0-2
7. Adequate organ functions, measured as follows:
White blood cells: >=2,000/mm3
Hemoglobin: >= 8.0g/dL
Thrombocyte: >= 7.5*104/mm3
Total birilbin: <= 1.5*ULN
AST (GOT): <=3*ULN
ALT (GPT): <=3*ULN
Serum creatinine: <=1.5*ULN
8. Time from prior therapy:
>= 2 weeks after the last administration date of prior chemotherapy
>= 2 weeks after the lastradiation date of prior radiotherapy
>= 4 weeks afer the date of last syrgery
>= 4 weeks after thelast treatment date of prior immunotherapy
9. Having written informed consent

Key exclusion criteria

1. Past history of severe hypersensitivity
2. Positive for HIV antibody
3. Experience of autoimmune disease requiring treatment during 6 months preceding the day of consent
4. Use of steroids (more than 20 mg equivalent of prednisolone/day) or immunosuppressive drugs
5. Patients with following severe complications
# severe heart disease or uncontrolled angina
# Uncontrolled diabetes mellitus
# Intestinal paresis or ileus
# Active infections requiring antibiotics
# Other severe complications
6. Pregnant or lactating women
7. Inappropriate for study entry judged by an attending physicians

Target sample size

18

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Kokura

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology

Zip code

Address

Kajiicho, kamigyo-ku, Kyoto

TEL

075-251-5519

Email

s-kokura@koto.kpu-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Takeshi Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology

Zip code

Address

Kaji-cho 465, Kamigyo-ku, Kyoto

TEL

075-251-5519

Homepage URL

Email

iskw-t@koto.kpu-m.ac.jp

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Department fo Immune-Gene Therapy/ Cancer Vaccine, Mie University

Name of secondary funder(s)

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

Date of disclosure of the study information

2012

Year

05

Month

15

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

Open public recruiting

Date of protocol fixation

2011

Year

05

Month

11

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

05

Month

15

Day

Last modified on

2015

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008508