Unique ID issued by UMIN | UMIN000032075 |
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Receipt number | R000035809 |
Scientific Title | Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas |
Date of disclosure of the study information | 2018/04/03 |
Last modified on | 2021/07/29 10:00:34 |
Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas
Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas
Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas
Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas
Japan |
initially diagnosed pediatric diffuse intrinsic pontine glioma (DIPG), adult brainstem glioma
Neurosurgery |
Malignancy
NO
A multicenter, investigators initiated phase II clinical trial to evaluate the efficacy of convection-enhanced delivery (CED) of nimustine hydrochloride against brainstem glioma.
Safety,Efficacy
Exploratory
Phase II
1 year survival rate of pediatric DIPG cases
・Overall survival of pediatric cases
・Response rate for pediatric cases
[Exploratory endpoints]
・Overall survival for adult cases
・Response rate for adult cases
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Device,equipment | Maneuver |
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 addition, patients can receive temozolomide chemotherapy from Day 1-5. Protocol for temozolomide will be that for recurrent glioma; 150 mg/m2 daily for 5 days.
3 | years-old | <= |
70 | years-old | >= |
Male and Female
<Key inclusion criteria for children>
1) MRI had to demonstrate that at least two-thirds of the tumor was situated in the pons and that the origin of the tumor was clearly within the pons.
2) Initially diagnosed patients with 3-21 years of age.
3) 28-35 days interval from prior radiation and/or chemotherapy. 56 days interval may be allowed for patients who got re-registered to the study.
4) Patients received no prior anti-tumor treatment except radiation and temozolomide chemotherapy.
5) KPS>=50 at screening.
6) Patients expected to be alive for more than 2 months.
7) Appropriate systemic condition: WBC(>=3,000/mm3), Hb(>=8.0 g/dl), Plt(>=100000/mm3), AST(<=100 IU/l), ALT(<=100 IU/l), Cre(<=1.5 mg/dl) should be cleared.
8) 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 or her approval.
<Key inclusion criteria for adult>
Initially diagnosed adult patients who fulfill #1, 3, 4, 5, 6, 7, 8 of the pediatric criteria. Recurrent adult patients who fulfill below mentioned #9 and 10 in addition to #1, 5, 6, 7, 8 of the pediatric criteria.
9) Patients with tumor enlargement or symptom deterioration after standard radiation therapy.
10) More than 28 days interval from prior anti-tumor treatment.
1) Co-existence of uncured cancer.
2) Patients with brain / spinal cord dissemination.
3) Women in pregnancy or possibly pregnant women or breast feeding women.
4) Patients who cannot take appropriate methods for contraception.
5) Infected patients who require systemic antibacterial or antiviral therapy.
6) Patients with hemorrhagic diathesis.
7) Patients taking anti-coagulants or anti-platelet agents within 21 days before clinical trials registry.
8) HBs antigen-positive patients.
9) Existence of mental disorder that makes participation to this study difficult.
10) Poor control of diabetes mellitus.
11) Patients who cannot undergo examinations or treatments required in this study.
12) Past history of pulmonary fibrosis or interstitial pneumoniae.
13) Patients with contraindication to MRI with contrast enhancement using gadolinium.
14) Patients with hypersensitivity to Nimustine hydrochloride (ACNU).
15) Patients participating in any other clinical trial.
16) Patients who should not be recruited to the clinical trial as determined by the investigators.
30
1st name | |
Middle name | |
Last name | Teiji Tominaga |
Tohoku University Graduate School of Medicine
Department of Neurosurgery
1-1 Seiryo-cho, Aoba-ku, Sendai
022-717-7230
tomi@nsg.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Aya Sato |
Tohoku University Hospital
Department of Neurosurgery
1-1 Seiryo-cho, Aoba-ku, Sendai
022-717-7230
http://www.nsg.med.tohoku.ac.jp/medical/
sato_a@nsg.med.tohoku.ac.jp
Tohoku University
Japan Agency for Medical Research and Development
Japanese Governmental office
Daiichi Sankyo Co., Fuji Systems Co.
NO
東北大学病院(宮城県)、山形大学医学部附属病院(山形県)、北里大学病院(神奈川県)、東京女子医科大学病院(東京都)、京都大学医学部附属病院(京都府)
2018 | Year | 04 | Month | 03 | Day |
Unpublished
No longer recruiting
2018 | Year | 03 | Month | 28 | Day |
2018 | Year | 02 | Month | 27 | Day |
2018 | Year | 04 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2018 | Year | 04 | Month | 03 | Day |
2021 | Year | 07 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035809
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