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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000005108 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Recurrent or refractory solid tumors | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | Has a double cancer.
Has a cardiac disease for which treatment is necessary. Has a psychosis or mental disorder. |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Organization | Osaka City General Hospital | ||||||
Division name | Pediatric Hematology/Oncology | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
keik-okada@hospital.city.osaka.jp |
Sponsor | |
Institute | Osaka City General Hospital |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health |
Organization | |
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Other related organizations | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |