UMIN-CTR Clinical Trial

Basic information
Public title	Autologous peripheral blood stem cell transplantation using Thiotepa, Carboplatin and Etoposide conditioning in patients with relapsed or refractory Medulloblastoma, Primitive neuroectodermal tumor (PNET) and Atypical teratoma and rhabdoid tumor (ATRT)
Acronym	Autologous peripheral blood stem cell transplantation using Thiotepa, Carboplatin and Etoposide conditioning in patients with relapsed or refractory Medulloblastoma, Primitive neuroectodermal tumor (PNET) and Atypical teratoma and rhabdoid tumor (ATRT)
Scientific Title	Autologous peripheral blood stem cell transplantation using Thiotepa, Carboplatin and Etoposide conditioning in patients with relapsed or refractory Medulloblastoma, Primitive neuroectodermal tumor (PNET) and Atypical teratoma and rhabdoid tumor (ATRT)
Scientific Title:Acronym	Autologous peripheral blood stem cell transplantation using Thiotepa, Carboplatin and Etoposide conditioning in patients with relapsed or refractory Medulloblastoma, Primitive neuroectodermal tumor (PNET) and Atypical teratoma and rhabdoid tumor (ATRT)
Region	Japan

Condition
Condition	relapsed or refractory Medulloblastoma, Primitive neuroectodermal tumor (PNET) and Atypical teratoma and rhabdoid tumor (ATRT)
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	efficacy and safety of autologous peripheral blood stem cell transplantation using Thiotepa, Carboplatin and Etoposide conditioning in patients with relapsed or refractory Medulloblastoma, Primitive neuroectodermal tumor (PNET) and Atypical teratoma and rhabdoid tumor (ATRT)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	day100 mortality
Key secondary outcomes

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	thiotepa 300mg/m2/day*3days carboplatin area under curve 7 mg/ml*min/day *3days etoposide 250mg/m2/day*3days
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	19 years-old >=
Gender	Male and Female
Key inclusion criteria	1 medulloblastoma, PNET, ATRT 2 refractory or relapsed 3 performance status is 0 to 2 4 Ejection Fraction is more than or equal to 50 percent 5 24hour creatinine clearance is more than or equal to 40ml/min/1.73m2 6 neutrophil count is more than or equal to 1*10 3/microL 7 platelet count is more than or equal to 50*10 3/microL 8 total bilirubin level is less than or equal to (5*upper limit of age reference value) mg/dL 9 AST(GOT) is less than or equal to (5*upper limit of age reference value) U/L 10 ALT(GPT) is less than or equal to (5*upper limit of age reference value) U/L 11 SpO2 is more than or equal to 95 percent 12 storage autologous peripheral blood stem cell
Key exclusion criteria	1 active double cancer 2 active infection needed systemic therapy 3 body temperature more than or equal to 38 degrees C 4 in pregnancy, breastfeeding, strong possibility of pregnancy 5 positive in HBs antigen, HBV-DNA, HCV antibody 6 positive in HIV antibody(no measurement is OK) 7 inadequate for other reason by doctor's assessment
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshiyuki Takahashi
Organization	Nagoya University Graduate School of Medicine
Division name	Pediatrics
Zip code
Address	65, Tsurumai-cho, Syowa-ku, Nagoya, Aichi
TEL	052-741-2111
Email	ytakaha@med.nagoya-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hideki Muramatsu
Organization	Nagoya University Graduate School of Medicine
Division name	Pediatrics
Zip code
Address	65, Tsurumai-cho, Syowa-ku, Nagoya, Aichi
TEL	052-741-2111
Homepage URL
Email	hideki-muramatsu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	ADIENNE Pharma & Biotech
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 01 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	2017 Year 04 Month 30 Day
Date of IRB	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2018 Year 06 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 10 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029719