UMIN-CTR Clinical Trial

Public title

Clinical study using denderitic cell vaccinations for cancer patients

Acronym

Clinical study using denderitic cell vaccinations for cancer patients

Scientific Title

Clinical study using denderitic cell vaccinations for cancer patients

Scientific Title:Acronym

Clinical study using denderitic cell vaccinations for cancer patients

Region

Japan

Condition

Malignancy

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To establish a multidisciplinary cancer therapy, we aim at developing a dendritic cell vaccine therapy to complement surgery, radiotherapy, and chemotherapy. A combination of dendritic-cell vaccine therapy and low-dose chemotherapy (dormant chemotherapy or metronome therapy) or minimally-invasive radiotherapy has a possibility of becoming a standard cancer therapy in the future.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The size of a measurable lesion is determined before and after therapy using various diagnostic imaging methods, such as CT, MRI, US, and PET. The sum of the longest diameters is calculated and evaluated based on the RECIST guideline as follows:
- Complete Response (CR): Disappearance (confirmed at 4 weeks)
- Partial Response (PR): ≥30% reduction (confirmed at 4 weeks)
- Stable Disease (discontinuation of disease progression): Neither PR nor PD criteria are met.
- Progressive Disease (PD): ≥20% increase (not diagnosed as CR, PR, or SD before the increase of a lesion)

Key secondary outcomes

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

Dendritic cell vaccine therapy
A vaccine of 10000000 dendritic cells per injection is transfused intradermally around the regional lymph node. The vaccine is injected intradermally every other week 1-7 times. Simultaneously, 1-5 KE picibanil is administered subcutaneously as an adjuvant around the injection site.

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) Patients with cancer intractable to standard therapies, including surgery, radiotherapy, and chemotherapy.
2) Patients with progressive cancer (stage III or IV) representing metastasis.
3) Patients with recurrent cancer after the completion of standard therapy.
4) Patients with cancer at high risk of relapse, who hope for the combined use of dendritic cell therapy as a standard therapy.
5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
6) Patients without severe organ dysfunction, infection, dysemia, and a bleeding tendency.
7) Patients without cardiovascular disorders, who can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells.
8) An excised tumor sample large enough to prepare a tumor cell lysate in order to conduct autologous dendritic cell therapy for cancer.
9) Informed consent to conduct this therapy as a medical treatment at the patient's own expense.

Key exclusion criteria

1) Pregnant or lactating women
2) ≥100 IU/l ALT or AST before the start of therapy
3) <50,000 platelet count
4) Allergy to penicillin or picibanil
5) Patients judged ineligible for the therapy by an attending physician
6) Juveniles
7) Adults with impaired judgment

Target sample size

250

Name of lead principal investigator

1st name
Middle name
Last name	Shinya Maejima1), Nobuyuki Udagawa2)

Organization

Matsumoto Dental University

Division name

1)Internal Medicine, 2)Oral Biochemistry

Zip code

Address

1780 Gobara, Hirooka, Shiojiri, Nagano

TEL

070-5014-3303

Email

udagawa@po.mdu.ac.jp

Name of contact person

1st name
Middle name
Last name	Megumi Tanaka

Organization

Matsumoto Dental University

Division name

Matsumoto Dental University Hospital

Zip code

Address

1780 Hiro-oka Gobara, Shiojiri, Nagano, Japan

TEL

0263-51-2353

Homepage URL

Email

mtanaka@po.mdu.ac.jp

Institute

Matsumoto Dental University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

2010

Year

04

Month

01

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

Preinitiation

Date of protocol fixation

2010

Year

03

Month

20

Day

Date of IRB

Anticipated trial start date

2010

Year

04

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

2010

Year

02

Month

24

Day

Last modified on

2013

Year

08

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003936