UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000026084
Receipt number	R000029719
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)
Date of disclosure of the study information	2017/05/01
Last modified on	2019/03/18 15:10:36

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

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

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

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

Research contact person

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

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 or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029719