UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017453 |
|---|---|
| Receipt number | R000012545 |
| Scientific Title | Clinical trial to evaluate the safety of Temsirolimus combined with Vincristine and Irinotecan in children with recurrent/refractory solid tumors |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2022/04/13 10:15:44 |
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Basic information
Public title
Clinical trial to evaluate the safety of Temsirolimus combined with Vincristine and Irinotecan in children with recurrent/refractory solid tumors
Acronym
Clinical trial to evaluate the safety of Temsirolimus combined with Vincristine and Irinotecan in children with recurrent/refractory solid tumors
Scientific Title
Clinical trial to evaluate the safety of Temsirolimus combined with Vincristine and Irinotecan in children with recurrent/refractory solid tumors
Scientific Title:Acronym
Clinical trial to evaluate the safety of Temsirolimus combined with Vincristine and Irinotecan in children with recurrent/refractory solid tumors
Region
| Japan |
Condition
Condition
childhood recurrent/refractory solid malignant tumors
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility study for the safety of temusilorimus dose in Japanese children with malignancy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Dose limiting toxicity of temusirolimus with the combination therapy of vincristin and irinotecan
Key secondary outcomes
Response rates and adverse eventsin
vincristin/irinotecan/temusirolimus combination study
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
Vincristin
Irinotecan
Temsilorimus
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
| 1 | days-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
recurrent/ reflactory childhood solid malignant tumors: neuroblastomaneuroblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing family tumor, retinoblastoma, nephroblastoma, hepatoblastoma, osteosarcoma, others (including brain tumors)
Key exclusion criteria
active double cancer
severe infection
abnormal ECG findings
intestinal pneumonia
etc.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Eiso |
| Middle name | |
| Last name | Hiyama |
Organization
Hiroshima University
Division name
Natural Center for Basic Research and Development
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5951
eiso@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kurihara |
Organization
Hiroshima University Hospital
Division name
Pediatric Surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5416
Homepage URL
http://home.hiroshima-u.ac.jp/eiso/
jplt@hiroshima-u.ac.jp
Sponsor or person
Institute
Natural Center for Basic Research and Development, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Study Group for Pediatric Liver Tumor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
Tel
082-257-5596
hugcp@hiroshima-u.ac.jp
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
http://home.hiroshima-u.ac.jp/eiso/
Publication of results
Unpublished
Result
URL related to results and publications
http://home.hiroshima-u.ac.jp/eiso/
Number of participants that the trial has enrolled
3
Results
This study was ended becasue the objected cases were enrolled and no DLTs appeared.
The safety of dose of temsirolimus (35 mg/m2) with the combination of Vincristin and Irrinotecan was confirmed.
Results date posted
| 2022 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1)Patients with metastatic disease, 2) cases with recurrence at least 1 month and less than 18 years of age, regardless of stage, or refractory pediatric solid tumors.
However, patients who are not considered viable for more than 3 months or who are judged to be unable to tolerate chemotherapy will be excluded.
It is imperative that written informed consent has been obtained from the patient's legally acceptable representative, and from the patient's legally acceptable representative, as well as the legally acceptable representative, for minors aged 16 years or older.
In addition, to combine with irinotecan, participants will be previously tested for UGT1A1 polymorphisms and selected after confirming that they are not homovariants and compound heterozygotes for UGT1A1*28/*28 or *6/*6.
Participant flow
The physician confirms that the target patient meets all eligibility criteria and does not meet any of the exclusion criteria, fills out all of the required items in the registration eligibility verification form, and submits the registration to the registrar by FAX or direct handover.
Adverse events
Neutrophil count decreased in Grade4 >1.7 days (168 hours)
2.1 Platelet count < 20,000 platelets per mm3 on two blood tests within a course or requiring two platelet transfusions in 7 days
3. Cytopenia that does not meet initiation criteria more than 14 days after the expected starting date of the next course (day22)
Nonhematologic toxicities
1. Non-haematological toxicities that may interfere with course initiation beyond Day 15 (day36) counting from the expected starting date of the next course (day22) (but not DLTs for allergic reactions and anaphylaxis related to vincristine, irinotecan or temsirolimus, even if leading to study treatment discontinuation)
2. Except for non-hematologic toxicity of Grade3, 4
Three enrolled patients will receive two courses each of the above VIT therapies to assess the presence or absence of DLT in each course.
Outcome measures
Among the above three cases,
1) VIT therapy is judged to be feasible if DLT expression is 0.
2) If there is one or two DLT episodes, three additional patients will be enrolled and if there are two or fewer DLT episodes out of six, VIT therapy will be considered feasible.
3) The clinical trial will be discontinued when at least 3 patients develop DLT.
However, if there are other patients on treatment who have already been enrolled, treatment can be continued for up to 2 courses as long as safety is ensured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012545
