UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011538 |
|---|---|
| Receipt number | R000013493 |
| Scientific Title | Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide after surgical resection of recurrent malignant gliomas at first recurrence / Phase I/II study |
| Date of disclosure of the study information | 2013/08/20 |
| Last modified on | 2018/12/14 09:37:58 |
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Basic information
Public title
Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide after surgical resection of recurrent malignant gliomas at first recurrence / Phase I/II study
Acronym
ACNU/CED plus oral TMZ after surgical resection of recurrent malignant gliomas at first recurrence
Scientific Title
Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide after surgical resection of recurrent malignant gliomas at first recurrence / Phase I/II study
Scientific Title:Acronym
ACNU/CED plus oral TMZ after surgical resection of recurrent malignant gliomas at first recurrence
Region
| Japan |
Condition
Condition
malignant glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I/II study to evaluate the safety and efficacy of combination of convection-enhanced delivery of nimustine hydrochloride and oral temozolomide after surgical resection of recurrent glioma at first recurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Determination of maximum tolerable concentration of ACNU
Phase II: 6 months progression free survival rate
Key secondary outcomes
Progression free survival, 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 | Maneuver |
Interventions/Control_1
First 3 cases receive convection- enhanced delivery of 20ml solution (volume is fixed to 20 ml throughout the study) of 0.25 mg/ml nimustine hydrochloride (mixed with 5mM Gd-DOTA: this concentration will be constant independent of concentration of ACNU). If no adverse event observed with this starting concentration, another 3 cases receive twice higher concentration, then 3 cases with 1.5 times higher concentration, then 3 cases with 1.2 times higher concentration. Concentration will be elevated by 1.2 times in this manner until severe adverse events will be recorded. If any severe adverse events observed within each 3 cases, another 3 cases receive the same concentration. If more than 3 in 6 cases suffer severe adverse events, this will be defined as dose-limiting toxicity (DLT). If dose-limiting toxicity was found in this method, the one step lower concentration will be defined as maximum tolerable concentration. If more than 2 cases out of 6 cases suffer severe adverse events at starting concentration, concentration will be cut to half. Concentration one-step lower than DLT will be defined as Maximum tolerable concentration (MTC). After determination of MTC, Phase II study using MTC will evaluate the efficacy of this treatment recruiting about 10 patients.
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) First recurred operable malignant glioma cases in patients who already received initial treatment with histological diagnosis of malignant glioma .
2) Recurrent cases after treatment with standard regimen; radiation plus oral temozolomide for grade IV or radiation plus intravenous ACNU for grade III.
3) Histological diagnosis of recurrent tumor from surgery performed within two weeks from initiation of CED of ACNU.
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 (<1.5 mg/dl) should be cleared (within 14days of study initiation)
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) Severe liver dysfunction (GOT>100 IU/l or GPT>100 IU/l)
5) Existence of bone marrow insufficiency: WBC(<2,000/mm3), Hb (<8.0 g/dl), Plt(<10x104/mm3)
6) Renal dysfunction: Cre (>1.5 mg/dl)
7) Existence of hemorrhagic diathesis
8) Patients taking anti-coagulants or anti-platelet agents.
9) Existence of mental disorder that makes participation to this study difficult.
10) Poor control of diabetes mellitus
11) Past history of acute myocardial infarction within 3 months or unstable angina.
12) Past history of pulmonary fibrosis or interstitial pneumoniae.
Target sample size
20
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
ryuta@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuta Saito |
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
Homepage URL
ryuta@nsg.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013493
