UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006334 |
|---|---|
| Receipt number | R000007506 |
| Scientific Title | A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma |
| Date of disclosure of the study information | 2011/09/12 |
| Last modified on | 2021/09/23 12:46:34 |
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Basic information
Public title
A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma
Acronym
A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma
Scientific Title
A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma
Scientific Title:Acronym
A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma
Region
| Japan |
Condition
Condition
recurrent malignant glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate efficacy and safety of temozolomide and ACNU combination chemotherapy for patients with recurrent malignant glioma. Based on the result of this trial, we determine whether temozolomide and ACNU combination chemotherapy is worth proceeding to the subsequent phase III trial or not.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
Key secondary outcomes
progression-free survival, response rate, adverse events
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 |
Interventions/Control_1
Temozolomide(150mg/m2 for 5days) (day 1,2,3,4,5)
+ ACNU(30-40mg/m2)(day14)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent
2) Age 20 years old or over
3) Expected survival time: more than 3 months.
4) Recurrence or regrowth of supratentorial tumor MRI
5) Anaplastic astrocytoma or glioblastoma
6) After initial treatment with radiation plus temozolomide
7) Gadolinium-enhanced tumor to measure
8) Tumor sample for central pathology review
9) Karnofsky Performance Status is 60% or more.
10) No prior chemotherapy or radiation therapy for any malignant diseases
11) Sufficient organ functions
12) Appropriate systemic condition: Neutrophil >1,500/mm3, Hb >8.0 g/dl, Plt>10x104/mm3, AST(GOT) <100 IU/l, ALT(GPT) <100 IU/l, total bilirubin <1.5 mg/dL, Cr <1.5 mg/dl.
Key exclusion criteria
1) After two chemotherapy regimens
2) Co-existence of uncured cancer.
3) Infection with systemic therapy indicated
4) fever over 38 degrees Celsius
5) Co-existence of meningitis
6) Women during pregnancy, possible pregnancy or breast-feeding
7) Psychosis
8) Uncontrollable diabetes mellitus or administration of insulin
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
10) Interstitial pneumonia, or fibroid lung
11) Patients who can 't receive gadolinium
12) After stereotactic radiation or boron neutron capture therapy
13) Symptomatic cerebrovascular disease
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-3459
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Arakawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-3459
Homepage URL
http://neurosur.kuhp.kyoto-u.ac.jp/
yarakawa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery
Kyoto University Graduate School of Medicine
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2011 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
not provided
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5243161/pdf/nmc-57-017.pdf
Number of participants that the trial has enrolled
49
Results
Eligible patients: 49(I:15, II:40).
Median age: 50.
Histology: glioblastoma(73%), anaplastic astrocytoma(22%), anaplastic oligodendroglioma(4%).
Phase I:
MTD: TMZ 150 mg/m2 plus ACNU 40 mg/m2.
Phase II:
Toxicity: mainly grade 3 or 4 hematological.
PFS at 6 and 12 months: 24%(95% CI, 12-35%) and 8% (95% CI, 4-15%).
Median PFS: 13 months (95% CI, 9.2-17.2 months).
OS at 6 and 12: 78% (95% CI, 67-89%) and 49% (95% CI, 33-57%).
Median OS: 11.8 months (95% CI, 8.2-14.5 months).
Results date posted
| 2021 | Year | 09 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5243161/table/T1/
Participant flow
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5243161/figure/F1/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5243161/table/T3/
Adverse events
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5243161/table/T2/
Outcome measures
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5243161/table/T4/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007506
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