UMIN-CTR Clinical Trial

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
Email	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/
Email	yarakawa@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Neurosurgery Kyoto University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007506