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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003983
Receipt No. R000004800
Scientific Title Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas
Date of disclosure of the study information 2010/08/03
Last modified on 2018/03/31

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Basic information
Public title Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas
Acronym CED of ACNU combined with oral TMZ against recurrent malignant gliomas
Scientific Title Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas
Scientific Title:Acronym CED of ACNU combined with oral TMZ against recurrent malignant gliomas
Region
Japan

Condition
Condition Recurrent malignant glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the safety of combination therapy of ACNU-CED and oral TMZ in order to overcome the drug resistance induced by MGMT
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Toxicity
Response of targeted lesion
Key secondary outcomes Best overall response

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 Device,equipment Maneuver
Interventions/Control_1 Convection-enhanced delivery of ACNU
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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathological diagnosis of recurrent malignant glioma. In case of brainstem gliomas, clinical diagnosis of diffuse brain stem glioma or malignant glioma should be sufficient.
2) Recurrent cases after standard therapy.
3) Inoperable cases or cases that refused surgical resection.
4) No treatment within 4 weeks before this study.
5) 6 years old or elder.
6) No systemic complication.
7) Informed consent is required.
Key exclusion criteria 1) Cases suffering active cancer
2) Cases suffering meningitis or pneumonia
3) Pregnant or breast feeding woman
4) Karnofsky performance status score less than 30
5) Cases suffering active inflammation
6) Cases with severe liver dysfunction
7) Cases with bone marrow insufficiency
8) Cases with renal failure
9) Cases with hemorrhagic diathesis
10) Cases taking anti-coagulative or anti-platelet agents
11) Cases with psychological diseases
12) Cases with uncontrolled Diabetes Mellitus
13) Cases suffered myocardial infarction within 3 months or cases with unstable angina
14) Cases that have history of pulmonary fibrosis or interstitial pneumoniae
Target sample size 10

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

Public contact
Name of contact person
1st name
Middle name
Last name Ryuta Saito
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
Homepage URL
Email ryuta@nsg.med.tohoku.ac.jp

Sponsor
Institute Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 東北大学病院 Tohoku University Hospital

Other administrative information
Date of disclosure of the study information
2010 Year 08 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 Completed
Date of protocol fixation
2008 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2013 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 02 Day
Last modified on
2018 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004800

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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