UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010929
Receipt number R000012777
Scientific Title Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Date of disclosure of the study information 2013/06/11
Last modified on 2019/06/17 10:28:05

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Basic information

Public title

Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors

Acronym

Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors

Scientific Title

Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors

Scientific Title:Acronym

Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors

Region

Japan


Condition

Condition

Malignant tumor

Classification by specialty

Medicine in general Hematology and clinical oncology Pediatrics
Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Evaluation of safety and antitumor effects on long-term administration of WT1 peptide vaccination

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety
Evaluation by NCI-CTCAE ver 4.0

Key secondary outcomes

1. Efficacy
2. Immune responses to WT1


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

Medicine Vaccine

Interventions/Control_1

The patient is intradermally injected with the WT1 peptide emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed every two or four weeks.

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

1 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Diagnosed as malignant solid tumors or acute leukemia and previously treated by WT1 vaccine.
2. Not expected to make any further efficacy by standard treatment
3. HLA-A*2402 positive
(In the vaccine-protocol using helper peptide, HLA class DRB1*04:05,15:01,15:02,08:03,HLA-DPB1*09:01 or 05:01 positive)
4. Judged as having clinical effects due to previous WT1 vaccine
5. Meet the following criteria for organ functions
1)Neutrophil more than 1,000/microliter, Platelet more than 50,000/microliter, Hemoglobin more than 7g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 2.0 mg/dL
4) Serum AST/GOT less than 4 folds of the upper normal limit
5) Arterial oxygen saturation more than 94% in room air
6. Age 0-85
7. Performance status (ECOG) 0-1
8. Informed consent has been obtained

Key exclusion criteria

1. There is deep-seated active infection.
2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial.
3. There is severe psychiatric disorder.
4. Responsible doctors judged the patient inappropriate for the trial

Target sample size

29


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruo Sugiyama

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cancer Immunology

Zip code


Address

1-7, Yamada-oka, Suita City, Osaka , Japan

TEL

06-6879-2593

Email

sugiyama@sahs.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Oji

Organization

Osaka University Graduate School of Medicine

Division name

Department of Clinical Laboratory Science

Zip code


Address

1-7, Yamada-oka, Suita City, Osaka , Japan

TEL

06-6879-2597

Homepage URL


Email

oji@sahs.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Cancer immunotherapy, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Donation for department of cancer immunotherapy in Osaka Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

大阪大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 11 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

2013 Year 06 Month 03 Day

Date of IRB

2013 Year 06 Month 03 Day

Anticipated trial start date

2013 Year 06 Month 03 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 11 Day

Last modified on

2019 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012777


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name