UMIN-CTR Clinical Trial

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
Condition	Recurrent or refractory solid tumors
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

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	1
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	12

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
Institute	Osaka City General Hospital
Institute
Department

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
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 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
URL(English)	https://upload.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

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