UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000314 |
|---|---|
| Receipt number | R000000408 |
| Scientific Title | Phase I-II clinical trial of irinotecan hydrochloride (CPT-11) for refractory pediatric solid tumors |
| Date of disclosure of the study information | 2006/01/27 |
| Last modified on | 2010/01/08 18:11:58 |
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Basic information
Public title
Phase I-II clinical trial of irinotecan hydrochloride (CPT-11) for refractory pediatric solid tumors
Acronym
CPT-PED-05
Scientific Title
Phase I-II clinical trial of irinotecan hydrochloride (CPT-11) for refractory pediatric solid tumors
Scientific Title:Acronym
CPT-PED-05
Region
| Japan |
Condition
Condition
Recurrent or progressive pediatric solid tumors (except for malignant lymphoma)
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I part: to evaluate maximum tolerating dose and dose-limiting toxicities to determine recommended dose of CPT-11 for recurrent or progressive pediatric solid tumors
Phase II part: to calculate response rate and validate the recommended dose based on frequency and degree of adverse events
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: dose limiting toxicity, response rate including patients entered in phase II part
Phase II: response rate including patients entered in phase I part
Key secondary outcomes
Progression-free survival, survival duration (median, 1-year survival rate), frequency of side effects, frequency of adverse events, severity and reversibility of each events, dose-response relationship, dose intensity, pharmacokinetics
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
Phase1 : Level1(4mg/m2/day) - level5 (6mg/m2/day). Evaluate 3 - 6 cases for each level. Fix certain dose level as MTD, where DLT once occurred. Define recommended dose (RD) at one rank lower level than MTD.
Phase2 : Adopt RD of Phase1. 3hr-div, day 1,2,3 and 8,9,10. 21days consist one cycle. Repeat up to 8 cycles unless the trial goes against discontinuation criteria of protocol triatment.
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
| 2 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) a patient who obtains diagnosis with the disease targeted in this trial with histological or cytological diagnosis
2) equal to, or more than 2 year-old, and less than 18 year-old of age
3) a patient who recurred or refractory to standard chemotherapy, or a patient who is unable to continue standard chemotherapy because of toxicities
4) a patient with measurable lesion (by RECIST)
5) more than 28 days period from the last date of therapy
6) a patient with at least 3 months of life-expectancy
7) performance status (Karnofsky/Lansky) equals to, or more than 50 points
8) a patient without serious organ failure
9) inpatient treatment at least during 1st course of chemotherapy
10)Informed consent from parents or guardian
Key exclusion criteria
1) a patient who received transfusion,
blood products, or hematopoietic growth factors such as G-CSF within 7 days prior to the registration
2) a patient who has another active malignant disease, which is untreated or whose control period is less than 5years, in different site
3) a patient with symptomatic metastasis to central nervous system, or a patient with primary central nervous system tumor
4) a patient who is complicated with serious disease as below;
1. infection, diarrhea, ileus, paralytic ileus
2. malignant fluid retention (pleural effusion, ascites, pericardiac effusion)
3. interstitial pneumonia or pulmonary fibrosis
4. cardiac disease
5. other disease which possibly interfere the trial
5) a patient who is pregnant, during breast-feeding, possibly pregnant, or willing to be pregnant
6) past history of serious drug allergy
7) past history of administration of CPT-11
8) a patient who was judged as inappropriate for the trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Makimoto |
Organization
National Cancer Center Hospital
Division name
Division of Pediatric Oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Makimoto |
Organization
National Cancer Center Hospital
Division name
Division of Pediatric Oncology
Zip code
Address
Division of Pediatric Oncology
TEL
03-3542-2511
Homepage URL
amakimot@ncc.go.jp
Sponsor or person
Institute
CPT-PED-05 administrative office
Institute
Department
Personal name
Funding Source
Organization
Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
治験届提出日2005年11月14日 届出回数26回
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 01 | Month | 27 | 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
| 2005 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 01 | Month | 27 | Day |
Last modified on
| 2010 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000408
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