UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003506
Receipt number R000004249
Scientific Title Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma
Date of disclosure of the study information 2010/04/19
Last modified on 2014/11/27 15:36:16

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Basic information

Public title

Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma

Acronym

Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma

Scientific Title

Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma

Scientific Title:Acronym

Fhase I clinical study of WT1 petide-based immnotherapy using WT1 helper peptide for recurrent malignant glioma

Region

Japan


Condition

Condition

Recurrent malignant glioma

Classification by specialty

Medicine in general Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Safety

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Safety

Key secondary outcomes

1. Antitumor effect (RECIST)
2. Performance status (ECOG)
3. Progression-free survival time
4. Immune response 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 3 mg of the HLA-A*2402-restricted, 9--mer modified WT1 peptide (p235-243:CYTWNQMN) and 0.75mg, 1.5mg or 3mg of 16-mer WT1 helper peptide (p 332-347:KRYFKLSHLQMHSRKH) emulsified with Montanide ISA51 adjuvant.
The WT1 vaccination was scheduled to be performed 5 times at weekly intervals. If problems happen, the vaccination interval may be changed to two weeks. The safety are evaluated by the NCI-CTC criteria from 1 to 2 weeks after 5th WT1 vaccination .

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

16 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Diagnosed as malignant glioma
2. Informed about his diagnosis
3. Not expected to make any further efficacy by standard treatment
4. WT1 expression in malignant cells
5. Having any one of HLA-class II type: HLA-DRB1*0405, 1501, 1502, 0803,HLA-DPB1*0901, 0501
6. Having evaluable diaseas
7. No chemotherapy/radiation has been performed within 4 weeks and no BRM therapy has been performed within 3 weeks before the start of vaccination.
8. Aged 16 and over, and 79 and under
9. Performance status (ECOG) 0-1
10. Meet the following criteria for organ functions
1) Neutrophil more than 1,500/microliter, Platelet more than 75,000/microliter, Hemoglobin more than 8g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 1.5 folds of the upper normal limit
4) Serum AST/GOT less than 4 folds of the upper normal limit
5) Serum Albumin more than 2.5g/dl
6) Arterial oxygen saturation more than 94% in room air
11. Pleural effusion, ascites and pericardial effusion are not detected or
controlled.
12. Survival period is expected more than 3 months
13. Informed consent has been obtained

Key exclusion criteria

1. There is deep-seated active infection.
2,3. 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.
4. Dependent on total parenteral nutrition(TPN)
5. There are other malignancies.
6. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD).
7. Post allogeneic hematopoietic stem cell transplantation
8. Pregnant or lactating woman
9. There is severe psychiatric disorder.
10. Responsible doctors judged the patient inappropriate for the trial

Target sample size

18


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 Functional Diagnosis

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 Akihiro Tsuboi

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cancer Immunotherapy

Zip code


Address

2-2, Yamada-oka, Suita City, Osaka , Japan

TEL

06-6879-3676

Homepage URL


Email

tsuboi@cit.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

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2010 Year 04 Month 19 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

2010 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 04 Month 19 Day

Last modified on

2014 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name