UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003983 |
|---|---|
| Receipt number | 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 18:57:51 |
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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
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
ryuta@nsg.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004800
