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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001037
Receipt No. R000001245
Scientific Title Phase I/II Study of Topotecan and Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors
Date of disclosure of the study information 2008/02/16
Last modified on 2014/02/10

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Basic information
Public title Phase I/II Study of Topotecan and Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors
Acronym TI chemotherapy for Relapsed Pediatric Solid Tumor pI/II
Scientific Title Phase I/II Study of Topotecan and Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors
Scientific Title:Acronym TI chemotherapy for Relapsed Pediatric Solid Tumor pI/II
Region
Japan

Condition
Condition Relapse/ refractory pediatric solid tumor
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To determine the maximum tolerated dose of topotecan when administered in combination with ifosfamide in pediatric patients with relapsed or primary refractory solid tumors
2. To determine the safety and efficacy of this regimen at the recommended dosage
3. To characterize the pharmacokinetics of topotecan in combination with ifosfamide in pediatric patients
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: MTD
Phase II: probability of the patients who can tolerate more than 4 courses of chemotherapy at the recommended dosage
Key secondary outcomes Phase I: incidence of dose limiting toxicity etc.
Phase II: progression free survival, overall survival etc.

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 TI chemotherpay in which ifosfamide IV over 1 hours followed by topotecan IV over 2 hours on days 1-5, to be repeated every 3 weeks
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 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria 1. neuroblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, retinoblastoma, Wilm's tumor, hepatoblastoma, osteosarcoma, other bone or tissue malignant tumor, meduloblastoma
2. relapse or progression following disease specific first-line standard chemotherapies
3. <= 20 courses prior chemotherapy
4. no or 5 years > prior allogenic stem cell transplantation
5. no prior topotecan containing chemotherapy
6. > 21 days since prior antitumor cytotoxic agents
7. > 21 days since prior radiation therapy
8. > 14 days since prior surgery (containing open biopsy)
9. evidence of progression in clinical signs or symptoms or on imaging studies
10. 0-2 in ECOG PS
11. no signs or symptoms equivalent to CTC-AE Grade3 neurology adverse events
12. confirming the following laboratory results within 14 days
(1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 75,000/mm~3 (platelet transfusions allowed)
(3) serum total Bilirubin <= 1.2mg/dl
(4) ALT <= 100 IU/l
(5) serum Potassium >= 3.0mmol/l
(6) Creatinine adjusted according to age as follows:
<= 0.6 mg/dl (1 year-23 months)
<= 0.8 mg/dl (2 years-5 years)
<= 0.9 mg/dl (6 years-9 years)
<= 1.1 mg/dl (10 years-12 years [male])
<= 1.0 mg/dl (10 years-12 years [female])
<= 1.5 mg/dl (13 years-15 years [male])
<= 1.2 mg/dl (13 years and over [female])
<= 1.7 mg/dl (16 years and over [male])

13. no episode of Status Epilepticus or at least 22 days since last episode of Status Epilepticus
14. no episode of Status Epilepticus within 48 hours after administration of ifosfamide
15. legal adult: Written informed consent
16. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian
17. 15 years and under: written informed consent from legal guardian
Key exclusion criteria 1. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment
2. Active infection requiring systemic medication
3. abnormality in electrocardiogram tested within 28 days, requiring intervention
4. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion
5. abnormality in electroencephalogram and requiring medication for neuropsychological signs or symptoms
6. Women during pregnancy or breast-feeding
7. Psychosis
8. Systemic steroids medication
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Ogawa
Organization Niigata Cancer Center Hospital
Division name Pediatric Division
Zip code
Address 2-15-3 Kawagishi-cho, Chuo-ku, Niigata 951-8566, Japan
TEL 025-266-5111
Email atsushi@niigata-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kawamoto
Organization study coordinator
Division name National Cancer Center Hospital
Zip code
Address 15-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL http://www.nposuccess.jp/datacenter/about_ti.html
Email hkawamot@ncc.go.jp

Sponsor
Institute Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan"
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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

Institutions
Institutions 国立がん研究センター中央病院(東京都)
日本大学医学部附属板橋病院(東京都)
静岡県立静岡がんセンター(静岡県)
新潟県立がんセンター新潟病院(新潟県)
大阪市立総合医療センター(大阪府)
滋賀医科大学附属病院(滋賀県)
国立病院機構九州がんセンター(福岡)
兵庫県立こども病院(兵庫)

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=42685
Number of participants that the trial has enrolled
Results
Recommended dose of topotecan with ifosfamide 1.2g/m2/d was determined to be level0. Currently phaseII is ongoing.
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
2007 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 02 Month 16 Day
Last modified on
2014 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001245

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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