UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas
Title of the study (Brief title)	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	Teiji Tominaga
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Neurosurgery
Address	1-1 Seiryo-cho, Aoba-ku, Sendai
TEL	022-717-7230
Email

Public contact
Name of contact person	Ryuta Saito
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Neurosurgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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