UMIN-CTR Clinical Trial

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

Recurrent glioblastoma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Safety

Key secondary outcomes

Efficacy: response on MRI and progression-free survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Neurosurgery
Kanazawa University

Institute

Department

Personal name

Organization

Department of Neurosurgery
Kanazawa University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2011

Year

02

Month

21

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/28423558

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

02

Month

20

Day

Last modified on

2020

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002506