UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014435
Receipt number R000016056
Scientific Title The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.
Date of disclosure of the study information 2014/06/30
Last modified on 2016/01/05 14:22:35

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Basic information

Public title

The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.

Acronym

The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides for malignant tumor.

Scientific Title

The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.

Scientific Title:Acronym

The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides for malignant tumor.

Region

Japan


Condition

Condition

Malignant tumor

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Endocrine surgery Breast surgery Obstetrics and Gynecology
Dermatology Orthopedics Urology
Oral surgery Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to assess the feasibility and clinical effects of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Safety:Adverse event

Key secondary outcomes

Immunological responses
Overall survival
Response of tumor-related markers


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Vaccine Maneuver

Interventions/Control_1

All patients are intradermally injected 5-7 times with dendritic cells in close proximity to the axial and/or inguinal lymph nodes. Injections are repeated every 14-21 days.

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) Patient must suffice the following conditions:
1. Either in the post-curative operation status or post-complete remission status, but is predicted at a certain rate for recurrence, and desires to receive the dendritic cell-based immunotherapy as a recurrence prevention measure.
2. Standard therapies including surgery, chemotherapy, and radiation therapies are not effective, or for whom relapse is a strong concern during or after standard treatments. A patient with recurrent, unresectable, and metastatic disease is also included.
3. An expected prognosis of more than 4 months and likely to complete the 5 - 7 administrations.
(2) The expression of cancer antigen to be used in the therapy has been confirmed with tumor markers or through other methods, such as RT-PCR or immunostaining, or has a type of cancer already verified of its expression in literature.
(3) With a lesion on which assessment is available.
(4) Performance status is 0-1.
(5) Not under any other clinical studies or trials.
(6) No serious vital organ dysfunction, infections, hematological disorder, or bleeding tendency.
(7) Has a sufficiently functioning cardiovascular system to undergo apheresis to extract peripheral blood mononuclear cells.
(8) Fully understands the given explanations concerning this therapy and consents to it.
(9) Other inclusion criteria are as follows:
White blood cell count of 2,000 cells/uL or higher
Hemoglobin level of 9.0 g/dL or higher
Platelet count of 80,000 counts/uL or higher
Systolic blood pressure: 90 mm Hg or higher, and lower 180 mm Hg
Temperature: 38.0 degree or less
(10) HTLV-1-negative or HIV-negative.

Key exclusion criteria

The patients have been
(1) Diagnosed or suspected of myelodysplastic syndrome (MDS).
(2) Suspected of other severe clinical conditions or abnormal laboratory values.
(3) Diagnosed or suspected of a mental disorder or mental symptoms.
(4) Suspected of immunodeficiency and/or infection.
Other exclusion criteria are as follows:
(5) Pregnant, lactating or suspected of pregnancy.
(6) Female patient rejecting to give consent to contraception during the therapy and for 70 days after the completion of the final administration.
(7) Taking in adrenocortical steroid (at the equivalent of 10mg predonine or prednisolone per day).
(8) Unsuitable for the therapy.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Morita

Organization

Medical Corporation Isokai Seren Clinic Tokyo

Division name

Oncology

Zip code


Address

Shirokanedai bldg 2-10-2 Shirokanedai Minatoku Tokyo Japan

TEL

03-3449-6095

Email

y.morita@serenclinic.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Kawakami

Organization

Medical Corporation Isokai Seren Clinic Tokyo

Division name

Purser department

Zip code


Address

Shirokanedai bldg 2-10-2 Shirokanedai Minatoku Tokyo Japan

TEL

03-3449-6131

Homepage URL


Email

k.kawakami@serenclinic.or.jp


Sponsor or person

Institute

Medical Corporation Isokai Seren Clinic Tokyo

Institute

Department

Personal name



Funding Source

Organization

tella, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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



Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 30 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

Terminated

Date of protocol fixation

2014 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 30 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

2014 Year 06 Month 30 Day

Last modified on

2016 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name