UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Convection enhanced delivery using ACNU and oral temozolomide therapy to treat recurrent spinal anstrocytoma
Title of the study (Brief title)	ACNU CED for recurrent spinal astrocytoma
Region	Japan

Condition
Condition	spinal cord astrocytoma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examine whether ACNU CED treatment is safe for recurrent spinal astrocytoma
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Determine maximum tolerable concentration of ACNU
Key secondary outcomes	Effectiveness, survival rate of 6 months, and overall survival

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
Interventions/Control_1	Catheter implantation (day1) ACNU (0.25 mg/ml or lower)+ Gd-DOTA(1mM) infusion (day1-2) and TMZ (200mg/m2) p.o. (day1-5)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) For those who suffer recurrent spinal cord astrocytoma and surgical treatment is not indicated. Cases include spinal cord originated tumors and disseminated lesion from intracranial astrocytoma. 2) For those who suffered recurrence after standard treatments including surgical removal, radiotherapy and chemotherapy. 3) For those who did not undertake any of the above mentioned treatment during the previous 4 weeks. 4) For those who have normal laboratory checkup. 5) For those who gave consent to be included in the exam.
Key exclusion criteria	1) For those suffering other cancer 2) For those suffering meningitis or pneumonia 3) Pregnant or Lactating women 4) For those suffering inflammation 5) For those suffering liver dysfunction 6) For those suffering myelo -suppression 7) For those suffering kidney dysfunction 8) For those having bleeding tendency or undertaking anti-coagulation or anti-platelet therapy 9) For those suffering psychiatric disorder 10) For those suffering uncontrolled Diabetes mellius 11) For those who have history of cardiac infarction in the last three months, or suffering angina pectoralis 12) For those having history of Idiopathic pulmonary fibrosis or interstitial pneumonia
Target sample size	15

Research contact person
Name of lead principal investigator	Teiji Tominaga
Organization	Tohoku University Graduate School of Medicine
Division name	Neurosurgery
Address	1-1 Seiryo Aoba Sendai Japan
TEL	022-717-7230
Email	profTT@nsg.med.tohoku.ac.jp

Public contact
Name of contact person	Toshiki Endo
Organization	Tohoku University Graduate School of Medicine
Division name	Neurosurgery
Address	1-1 Seiryo Aoba Sendai Japan
TEL	022-717-7230
Homepage URL	http://www.nsg.med.tohoku.ac.jp/medical/id=55
Email	endo@nsg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University, Graduate school of medicine, Department of Neurosurgery
Institute
Department

Funding Source
Organization	Tohoku University
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

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 09 Month 09 Day
Anticipated trial start date	2011 Year 09 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 08 Month 30 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017447