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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000314
Receipt No. 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

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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
Email

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
Email amakimot@ncc.go.jp

Sponsor
Institute CPT-PED-05 administrative office
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000408

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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