UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032075
Receipt number R000035809
Scientific Title Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas
Date of disclosure of the study information 2018/04/03
Last modified on 2021/07/29 10:00:34

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Basic information

Public title

Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas

Acronym

Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas

Scientific Title

Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas

Scientific Title:Acronym

Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas

Region

Japan


Condition

Condition

initially diagnosed pediatric diffuse intrinsic pontine glioma (DIPG), adult brainstem glioma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A multicenter, investigators initiated phase II clinical trial to evaluate the efficacy of convection-enhanced delivery (CED) of nimustine hydrochloride against brainstem glioma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

1 year survival rate of pediatric DIPG cases

Key secondary outcomes

・Overall survival of pediatric cases
・Response rate for pediatric cases

[Exploratory endpoints]
・Overall survival for adult cases
・Response rate for adult cases


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 Device,equipment Maneuver

Interventions/Control_1

On Day 1, catheter will be inserted into the targeted site with the method of stereotactic neurosurgery. After the MR imaging, infusion of the drug; Nimustine hydrochloride, will be started. 7 ml Nimustine hydrochloride at concentration of 0.75 mg/ml, which is a predefined maximum tolerable concentration from preceding Phase I study, will be used in this study. In addition, patients can receive temozolomide chemotherapy from Day 1-5. Protocol for temozolomide will be that for recurrent glioma; 150 mg/m2 daily for 5 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

3 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

<Key inclusion criteria for children>
1) MRI had to demonstrate that at least two-thirds of the tumor was situated in the pons and that the origin of the tumor was clearly within the pons.
2) Initially diagnosed patients with 3-21 years of age.
3) 28-35 days interval from prior radiation and/or chemotherapy. 56 days interval may be allowed for patients who got re-registered to the study.
4) Patients received no prior anti-tumor treatment except radiation and temozolomide chemotherapy.
5) KPS>=50 at screening.
6) Patients expected to be alive for more than 2 months.
7) Appropriate systemic condition: WBC(>=3,000/mm3), Hb(>=8.0 g/dl), Plt(>=100000/mm3), AST(<=100 IU/l), ALT(<=100 IU/l), Cre(<=1.5 mg/dl) should be cleared.
8) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his or her approval.

<Key inclusion criteria for adult>
Initially diagnosed adult patients who fulfill #1, 3, 4, 5, 6, 7, 8 of the pediatric criteria. Recurrent adult patients who fulfill below mentioned #9 and 10 in addition to #1, 5, 6, 7, 8 of the pediatric criteria.
9) Patients with tumor enlargement or symptom deterioration after standard radiation therapy.
10) More than 28 days interval from prior anti-tumor treatment.





Key exclusion criteria

1) Co-existence of uncured cancer.
2) Patients with brain / spinal cord dissemination.
3) Women in pregnancy or possibly pregnant women or breast feeding women.
4) Patients who cannot take appropriate methods for contraception.
5) Infected patients who require systemic antibacterial or antiviral therapy.
6) Patients with hemorrhagic diathesis.
7) Patients taking anti-coagulants or anti-platelet agents within 21 days before clinical trials registry.
8) HBs antigen-positive patients.
9) Existence of mental disorder that makes participation to this study difficult.
10) Poor control of diabetes mellitus.
11) Patients who cannot undergo examinations or treatments required in this study.
12) Past history of pulmonary fibrosis or interstitial pneumoniae.
13) Patients with contraindication to MRI with contrast enhancement using gadolinium.
14) Patients with hypersensitivity to Nimustine hydrochloride (ACNU).
15) Patients participating in any other clinical trial.
16) Patients who should not be recruited to the clinical trial as determined by the investigators.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teiji Tominaga

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Neurosurgery

Zip code


Address

1-1 Seiryo-cho, Aoba-ku, Sendai

TEL

022-717-7230

Email

tomi@nsg.med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Aya Sato

Organization

Tohoku University Hospital

Division name

Department of Neurosurgery

Zip code


Address

1-1 Seiryo-cho, Aoba-ku, Sendai

TEL

022-717-7230

Homepage URL

http://www.nsg.med.tohoku.ac.jp/medical/

Email

sato_a@nsg.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Daiichi Sankyo Co., Fuji Systems Co.

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

東北大学病院(宮城県)、山形大学医学部附属病院(山形県)、北里大学病院(神奈川県)、東京女子医科大学病院(東京都)、京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 03 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

No longer recruiting

Date of protocol fixation

2018 Year 03 Month 28 Day

Date of IRB

2018 Year 02 Month 27 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2021 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

2018 Year 04 Month 03 Day

Last modified on

2021 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035809


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name