UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025033 |
|---|---|
| Receipt number | R000028810 |
| Scientific Title | Phase II study of Convection-enhanced delivery of Nimustine Hydrochloride combined with systemic Temozolomide against recurrent gliomas at brainstem |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2021/07/29 10:08:06 |
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Basic information
Public title
Phase II study of Convection-enhanced delivery of Nimustine Hydrochloride combined with systemic Temozolomide against recurrent gliomas at brainstem
Acronym
ACNU/CED plus systemic TMZ against recurrent gliomas at brainstem: Phase II study
Scientific Title
Phase II study of Convection-enhanced delivery of Nimustine Hydrochloride combined with systemic Temozolomide against recurrent gliomas at brainstem
Scientific Title:Acronym
ACNU/CED plus systemic TMZ against recurrent gliomas at brainstem: Phase II study
Region
| Japan |
Condition
Condition
recurrent glioma at brainstem
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase II study to evaluate the efficacy of combination of convection-enhanced delivery of nimustine hydrochloride and systemic temozolomide against recurrent glioma at brainstem.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Determination of 3.5 months survival rate for pediatric cases and 6 months survival for adult cases
Key secondary outcomes
Overall survival, Response rate, and Adverse events
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 | Device,equipment | Maneuver |
Interventions/Control_1
On Day 1, catheter will be inserted into the targeted site with the method of stereotactic neurosurgery. After the MR imaging, infusion of the drug; Nimustine hydrochloride, will be started. 7 ml Nimustine hydrochloride at concentration of 0.75 mg/ml, which is a predefined maximum tolerable concentration from preceding Phase I study, will be used in this study. In order to monitor drug distribution during infusion, 5mM Gd-DOTA will be mixed into the infusion solution. In addition, patients will receive temozolomide chemotherapy from Day 1-5. Protocol for temozolomide will be that for recurrent glioma; 200mg/m2 daily for 5 days.
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) Cases diagnosed clinically as well as radiologically as recurrent glioma at brainstem will be recruited. Recurrent cases of diffuse brainstem glioma as well as recurrent cases of gliomas originating from surrounding structure, i.e. thalamus, cerebellum, etc, and infiltrating brainstem will be included. In the recurrent cases of glioma originating from surrounding structure, histological diagnosis of the initial tumor is necessary. Since the disease occupy brainstem region, histological diagnosis of brainstem lesion is not necessary.
2) Recurrent cases after treatment with radiation therapy.
3) At least 4 weeks interval from prior radiation and/or chemotherapy.
4) Appropriate systemic condition: WBC (>3,000/mm3), Hb (>8.0 g/dl), Plt (>10x104/mm3), GOT (<100 IU/l), GPT (<100 IU/l), Cre (adult<1.5 mg/dl, pediatric<2 x upper limitation of corresponding age and sex) should be cleared
5) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his approval.
Key exclusion criteria
1) Co-existence of uncured cancer.
2) Co-existence of meningitis or pneumonia that require treatment.
3) Women in pregnancy or possibly pregnant women or breast feeding women
4) Existence of active inflammation (CRP>2.0)
5) Severe liver dysfunction (GOT>100 IU/l or GPT>100 IU/l)
6) Existence of bone marrow insufficiency: WBC(<3,000/mm3), Hb (<8.0 g/dl), Plt(<10x104/mm3)
7) Renal dysfunction: Cre (adult >1.5 mg/dl, pediatric > 2 x upper limitation of corresponding age and sex)
8) Existence of hemorrhagic diathesis
9) Patients taking anti-coagulants or anti-platelet agents.
10) Existence of mental disorder that makes participation to this study difficult.
11) Poor control of diabetes mellitus
12) Past history of acute myocardial infarction within 3 months or unstable angina.
13) Past history of pulmonary fibrosis or interstitial pneumoniae.
Target sample size
35
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
tomi@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuta Saito |
Organization
Tohoku University Hospital
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
Tohoku University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2021 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028810
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