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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005111
Receipt No. R000002506
Scientific Title Chemotherapy for recurrent malignant glioma with combined usage of temozolomide and GSK3beta-inhibiting drugs
Date of disclosure of the study information 2011/02/21
Last modified on 2020/02/13

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Basic information
Public title Chemotherapy for recurrent malignant glioma with combined usage of temozolomide and GSK3beta-inhibiting drugs
Acronym GSK3beta inhibitor for recurrent malignant glioma
Scientific Title Chemotherapy for recurrent malignant glioma with combined usage of temozolomide and GSK3beta-inhibiting drugs
Scientific Title:Acronym GSK3beta inhibitor for recurrent malignant glioma
Region
Japan

Condition
Condition Recurrent glioblastoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is undertaken to evaluate the safety and efficacy of combined usage of temolzolomide and GSK3beta-inhibiting drugs for recurrent glioblastoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes Efficacy: response on MRI and progression-free survival

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
Interventions/Control_1 GSK cocktail is daily administered from the detection of recurrence until unavailable state.
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) age: 15<, 90>
2)Treatment-failure glioblastoma multiforme patients who have been histologically diagnosed as glioblastoma multiforme.
3)No allergy to the drugs administered.
4) Sufficient function of vital organs including heart, lung, liver, kidney and bone marrow.
5) No obstacles on drug administration.
6) Written informed consents are obtained from patients after giving sufficient explanations and obtaining their understandings about disease conditions.
Key exclusion criteria 1) Allergy to the drugs administered.
2) Patients who are pregnant and/or breast feeding.
3) Any patients disqualified by a study physician because of medical, psychological, or any other factors.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun-ichiro Hamada
Organization Kanazawa University
Division name Department of Neurosurgery
Zip code
Address 13-1 Takaramachi, Kanazawa
TEL 076-265-2384
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsutoshi Nakada
Organization Kanazawa University
Division name Department of Neurosurgery
Zip code
Address 13-1 Takaramachi, Kanazawa
TEL 076-265-2384
Homepage URL
Email

Sponsor
Institute Department of Neurosurgery
Kanazawa University
Institute
Department

Funding Source
Organization Department of Neurosurgery
Kanazawa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 金沢大学病院(石川県)(Kanazawa University Hospital)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 21 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/28423558
Publication of results Unpublished

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28423558
Number of participants that the trial has enrolled 7
Results
Seven patients were enrolled in this study. Median OS after first recurrence was 11.2 (95% CI, 3.8-18.6) months in patients treated with concomitant CLOVA cocktail with maintenance TMZ although they were classified into RPA class 7 wherein the median survival duration was estimated as 4.9 months, compared to median OS of 4.3 (95% CI, 2.5-6.1) months in historical control group (log-rank test, P = 0.004). The concomitant CLOVA cocktail with TMZ was safe and well tolerated.
Results date posted
2020 Year 02 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
 All patients were eligible following radiological disease progression and classified as Recursive Partitioning Analysis (RPA) class 7. Median age was 66 years and median KPS was 50. MGMT promoter methylation was determined in 4 patients (57%). Three patients took CLOVA cocktail on the day before death and 4 patients discontinued the oral medication because of aspiration pneumonitis, 2 weeks before death. 
Participant flow
see above
Adverse events
Most common treatment-related AE was grade 1/2 somnolence caused by antipsychotic drug constituents of CLOVA cocktail.
Outcome measures
see above
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 06 Month 11 Day
Date of IRB
2009 Year 07 Month 31 Day
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2016 Year 01 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
2011 Year 02 Month 20 Day
Last modified on
2020 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002506

Research Plan
Registered date File name
2020/02/13 臨床研究実施計画書 GSK3beta.doc

Research case data specifications
Registered date File name
2020/02/13 Furuta GSK Oncotarget 2017.pdf

Research case data
Registered date File name
2020/02/13 Furuta GSK Oncotarget 2017.pdf


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