UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011854
Receipt number R000013855
Scientific Title Phase I study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma
Date of disclosure of the study information 2013/10/01
Last modified on 2016/09/26 09:03:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase I study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma

Acronym

Phase I study of DC immunotherapy for HCC patients

Scientific Title

Phase I study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma

Scientific Title:Acronym

Phase I study of DC immunotherapy for HCC patients

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for advanced HCC patients refractory to standard therapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Adverse events

Key secondary outcomes



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

Administration of DC vaccine 7 times, every two weeks, which quality was well controlled for three weeks culture and maturation of DCs after apheresis.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Diagnostic imaging of HCC that can be evaluated by RECIST
2) Refractory HCC for standard therapies or recurrence HCC after hepatectomy with chemotherapy and/or radiation therapy resistance
3) Performance status (ECOG) 0, 1, 2
4) Patients expected for completion of 7 times administration of DC vaccination
5) Adequate hematologic, hepatic, renal, and cardiac function
WBC >= 1,500/mm3
Absolute lymphocyte count >= 500/mm3
Hemoglobin >= 8.0g/dL
Total bilirubin <= 2.0mg/dL
Creatinine <= 2.0 mg/dL
Platelet >= 50,000/mm3
AST and ALT within 5 times of reference value
6) Written informed consent

Key exclusion criteria

1) Sever hemorrhagic diathesis
PT <50%
APTT >60%
Doctors judgment of severe bleeding tendency
2) Carrier of HBV, HTLV-1, HIV and so on
3) Severe comorbidity of heart disease (NYHA classIII, IV)
4) Intolerable cardiovascular disease for the apheresis
5) Past history of autoimmune disease (PSS, Sjogren syndrome, ITP, MS, RA etc.)
6) During treatment with immunosuppressive agents
7) Severe allergy with penicillin or picibanil
8) Pantients with adverse events of CTCAE v4.0 >= grade 3 of nonhematological toxicity, or >= grade 4 of hematological toxicity
9) Pregnancy, nursing women
10) Male hope to impregnate
11) Patients whom doctors judged inadequate to the enrollment of this study by other reasons

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiichi Suzuki

Organization

Kitasato Institute Hospital

Division name

Surgery

Zip code


Address

5-9-1, Shirogane, Minato-ku, Tokyo, Japan

TEL

+81-3-3444-6161

Email

k1suzuki@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Takeuchi

Organization

Kitasato Institute Hospital

Division name

Biomedical laboratory

Zip code


Address

5-9-1, Shirogane, Minato-ku, Tokyo, Japan

TEL

+81-3-3444-6161

Homepage URL


Email

take-osa@insti.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

Tella, Inc


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

北里研究所病院


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 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

2013 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 05 Day

Last follow-up date

2014 Year 06 Month 01 Day

Date of closure to data entry

2014 Year 07 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 24 Day

Last modified on

2016 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013855


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name