UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000005108
Receipt number	R000006075
Scientific Title	Pilot study of bevacizumab and irinotecan in children with recurrent or refractory solid tumors.
Date of disclosure of the study information	2011/02/19
Last modified on	2012/02/22 12:31:18

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Basic information

Public title

Pilot study of bevacizumab and irinotecan in children with recurrent or refractory solid tumors.

Acronym

Pilot study of bevacizumab in children with recurrent/refractory solid rumors.

Scientific Title

Pilot study of bevacizumab and irinotecan in children with recurrent or refractory solid tumors.

Scientific Title:Acronym

Pilot study of bevacizumab in children with recurrent/refractory solid rumors.

Region

Japan

Condition

Recurrent or refractory solid tumors

Classification by specialty

Hematology and clinical oncology Pediatrics

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Determining the dose-limiting toxicities (DLTs) and estimating the maximum-tolerated dose (MTD) of Bevacizumab and irinotecan.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase I

Assessment

Primary outcomes

Determine the DLTs.

Key secondary outcomes

Estimate the rate of treatment-related toxicity.

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

Bevacizumab and irinotecan are administered i.v., once every 2 weeks: days 1, 15 and 29 of a 6-week cycle. Irinotecan is administered over 90 min before the bevacizumab infusion. Bevacizumab is administered 60-90 min. Treatment repeats every 2 weeks for up to 3 cycles in the absence of unacceptable toxicity or tumor progression.

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

0 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Diagnosis of pediatric solid tumors or brain tumors.
Recurrent, progressive, or refractory disease (must have received prior therapy)
No evidence of CNS hemorrhage within the past 2 weeks.
At least 3 weeks since prior anticancer chemotherapy.
More than 7 days since prior minor surgery, and at least 6 weeks since prior major surgery.
At least 3 months since prior autologous bone marrow or stem cell transplantation.
More than 12 weeks since prior irradiation.
No concurrent therapeutic anticoagulation.
No concurrent non-steroidal anti-inflammatory drugs.
Karnofsky performance status (PS) 50-100%.
At least 72 hours since prior G-CSF.
Absolute neutrophil count >500/mm3
Platelet count >75000/mm3
ALT and AST < 2.5 times ULN
Bilirubin < 1.5 mg/dl
No uncontrolled systemic hypertension.
No stroke, myocardial infarction, unstable angina, or peripheral vascular disease.
No evidence of bleeding diathesis, or coagulopathy.
No significant traumatic injury within the past 6 weeks.
No abdominal fistula or gastrointestinal perforation within the past 6 months.
No pregnant or nursing.

Key exclusion criteria

Has a double cancer.
Has a cardiac disease for which treatment is necessary.
Has a psychosis or mental disorder.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Junichi Hara

Organization

Osaka City General Hospital

Division name

Pediatric Hematology/Oncology

Zip code

Address

2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name Keiko Okada

Organization

Osaka City General Hospital

Division name

Pediatric Hematology/Oncology

Zip code

Address

TEL

Homepage URL

Email

keik-okada@hospital.city.osaka.jp

Sponsor or person

Institute

Osaka City General Hospital

Institute

Department

Personal name

Funding Source

Organization

Ministry of Health

Organization

Division

Category of Funding Organization

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

Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 19 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

2009 Year 02 Month 27 Day

Date of IRB

Anticipated trial start date

2009 Year 02 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2011 Year 02 Month 19 Day

Last modified on

2012 Year 02 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006075

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name