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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032075
Receipt No. 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 2018/05/14

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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
Institute Tohoku University
Institute
Department

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 28 Day
Date of IRB
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
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.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


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