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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000005125 |
Receipt No. | R000006092 |
Scientific Title | Phase I study of Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide against recurrent gliomas at brainstem |
Date of disclosure of the study information | 2011/02/22 |
Last modified on | 2018/03/31 |
Basic information | ||
Public title | Phase I study of Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide against recurrent gliomas at brainstem | |
Acronym | CED of ACNU plus oral TMZ against recurrent gliomas at brainstem: Phase I study | |
Scientific Title | Phase I study of Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide against recurrent gliomas at brainstem | |
Scientific Title:Acronym | CED of ACNU plus oral TMZ against recurrent gliomas at brainstem: Phase I study | |
Region |
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Condition | ||
Condition | recurrent glioma at brainstem | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Phase I study to evaluate the safety of combination of convection-enhanced delivery of nimustine hydrochloride and oral temozolomide against recurrent glioma at brainstem. This study is designed to find the appropriate dose of nimustine hydrochloride. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | Determination of maximum tolerable concentration of ACNU |
Key secondary outcomes | Response rate, 6 months 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 |
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Interventions/Control_1 | First 3 cases receive convection- enhanced delivery of 7ml solution (volume is fixed to 7 ml throughout the study) of 0.25 mg/ml nimustine hydrochloride (mixed with 1mM 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. If dose-limiting toxicity was found in this method, the one step lower concentration will be defined as maximum tolerable concentration. If more than 3 cases out of 6 cases suffer severe adverse events at starting concentration, concentration will be cut to half. MRI obtained at least 14 days after initiation of CED need to be evaluated to determine the existence of adverse events. | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 standard regimen; radiation plus oral temozolomide. 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 (<1.5 mg/dl) should be cleared (within 14days of study initiation) 5) Informed consent taken from the patient. If 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. |
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Key exclusion criteria | 1) Co-existence of uncured cancer.
2) Co-existence of meningitis or pneumonia that require treatment. 3) Pregnant women 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 (>1.5 mg/dl) 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. |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |
Institute | Department of Neurosurgery, Tohoku University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Tohoku University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 東北大学病院 Tohoku University Hospital |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006092 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |