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