UMIN-CTR Clinical Trial

Public title

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with malignant glioma.

Acronym

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with malignant glioma.

Scientific Title

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with malignant glioma.

Scientific Title:Acronym

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with malignant glioma.

Region

Japan

Condition

Malignant Glioma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Safety

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Safety

Key secondary outcomes

1. Relapse-free survival time
2. Immune response to WT1

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

Medicine

Vaccine

Interventions/Control_1

The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, modified 9-mer WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be started from 2 weeks after Radiation (RT) and Temozolomide (TMZ) and performed 6 times at weekly intervals. If problems happen, the vaccination interval may be changed to two weeks.
Temozolomide is given daily for five days from 4 weeks after RT/TMZ according to standard therapy.
The safety are evaluated by the NCI-CTC criteria from 1 to 3 weeks after 6th 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

Age-lower limit

16

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Diagnosed as malignant glioma
2. Informed about his diagnosis
3. WT1 expression in malignant cells
4. HLA-A*2402 positive
5. Require no evaluable diaseas
6. Aged 15 and over, and 79 and under
7. Performance Status (ECOG) 0-2
8. Followed by Operation, Radiation and Temozolomide
9. Meet the following criteria for organ functions
1)Neutrophil more than 1,000/microliter, Platelet more than 50,000/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
10. Pleural effusion, ascites and pericardial effusion are not detected or
controlled.
11. Survival period is expected more than 3 months
12. 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

3

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

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

Institute

Department of Cancer immunotherapy, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

19

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

Completed

Date of protocol fixation

2010

Year

03

Month

11

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

2013

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related 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=R000004239