UMIN-CTR Clinical Trial

Public title

Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer

Acronym

Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer (DC5)

Scientific Title

Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer

Scientific Title:Acronym

Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer (DC5)

Region

Japan

Condition

Advanced or recurrent esophageal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the safety of the WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Advertise events

Key secondary outcomes

Response rate
Progression free survival
Overall survival
Immune induction (Delayed type hypersensensitivity DTH for WT1 peptide)

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

Docetaxel 50 mg/m2/day day1
Dendritic cell day15,22
q4w , 3 cycle

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Primary lesion is located at cervical or thoracic or abdominal esophagus
2)Histological diagnosis of esophageal cancer(adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma)
3)Patients with progressive disease treated by 5FU and cisplatin
4)Possess HLA-A2402
5)Obtains lesion that can be evaluated by RECIST
6)performance status (ECOG) 0,1,2
7) Adequate hematologic, hepatic, renal, and cardiac function
a)WBC >=3,000/mm3
b)Absolute neutrophil count 1,500/mm3
c)Platelet >=100,000/mm3
d)Hemoglobin >=9.0g/dL
e)AST and ALT <=100IU/L
f)Total bilirubin <1.5mg/dL
g)Creatinine <1.5mg/dL
h)ECG normal
8)Four weeks or more must pass from the prior treatment
9)Written informed consent
Edit
10)Previously treated-patient with 5-FU, cisplatin and/or docetaxel and/or radiotherapy.

Key exclusion criteria

1)Tracheo-esophageal fistula
2)Symptomatic brain metastasis
3)Active other primary malignancies
4)Past history of severe allergy
5)Severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes)
6)Pleural effusion or pericardial fluid requiring treatment
7)Pregnancy, nursing women
8)Male hope to impregnate
9)Severe psychiatric disease
10)Active autoimmune disease
11)During treatment with immunosuppressive agents
12)Patients whom doctors judged inadequate to the enrollment of this study by other reasons

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yuko Kitagawa

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

+813-5363-3802

Homepage URL

Email

Institute

School of Medicine, Keio University

Institute

Department

Personal name

Organization

Tella, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Tokyo Midtown Medical Center

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

2011

Year

11

Month

14

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

2011

Year

10

Month

14

Day

Date of IRB

2011

Year

10

Month

20

Day

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

2016

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

11

Month

11

Day

Last modified on

2019

Year

12

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007925