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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020144
Receipt No. R000023239
Scientific Title Phase I/II Study of Irinotecan and Gemcitabine in Pediatric, adolescent and Young Adult Patients with Relapsed or Refractory Solid Tumors
Date of disclosure of the study information 2015/12/11
Last modified on 2020/04/17

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Basic information
Public title Phase I/II Study of Irinotecan and Gemcitabine in Pediatric, adolescent and Young Adult Patients with Relapsed or Refractory Solid Tumors
Acronym IG chemotherapy for Relapsed Pediatric/AYA Solid Tumor pI/II
Scientific Title Phase I/II Study of Irinotecan and Gemcitabine in Pediatric, adolescent and Young Adult Patients with Relapsed or Refractory Solid Tumors
Scientific Title:Acronym IG chemotherapy for Relapsed Pediatric/AYA Solid Tumor pI/II
Region
Japan

Condition
Condition Relapse/refractory pediatric/AYA solid tumor
Classification by specialty
Hematology and clinical oncology Pediatrics Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To determine the maximum tolerated dose of gemcitabine when administered in combination with irinotecan in pediatric/AYA 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 irinotecan and gemcitabine in combination therapy in pediatric/AYA 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: Progression-free survival
Key secondary outcomes Phase I: incidence of adverse event
Phase II: probability of the patients who can tolerate more than 4 courses of chemotherapy at the recommended dosage, 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 IG chemotherapy in which irinotecan IV over 1 hour on days 1-5 and gemcitabine IV over 30 minutes on days 1, 8, 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
40 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
2. relapse or progression following disease specific first-line standard chemotherapies
3. evidence of progression in clinical signs or symptoms or on imaging studies
4. > 21 days since prior antitumor cytotoxic agents
5. > 21 days since prior radiation therapy
6. > 14 days since prior surgery (containing open biopsy)
7. no prior combination of irinotecan and gemcitabine containing chemotherapy
8. 0-2 in ECOG PS
9. confirming the following laboratory results
(1) Absolute neutrophil count >= 1,000/mm3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 75,000/mm3 (platelet transfusions allowed)
(3) Direct Bilirubin < 1.5mg/dl
(4) Creatinine adjusted according to age as follows:
<= 1.0 mg/dl (1 year-23 months)
<= 1.4 mg/dl (2 years-5 years)
<= 1.8 mg/dl (6 years-9 years)
<= 2.3 mg/dl (10 years-12 years [male])
<= 2.1 mg/dl (10 years-12 years [female])
<= 2.9 mg/dl (13 years-15 years [male])
<= 2.3 mg/dl (13 years and over [female])
<= 3.0 mg/dl (16 years-17 years [male])
<= 2.3 mg/dl (16 years-17 years [female])
<= 3.0*ULN mg/dl (16 years and over)
(5) SpO2 >= 94% without oxygenation
10. written informed consent from patient and / or 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. diarrhea >= Grade2
6. Women during pregnancy or breast-feeding
7. Psychosis
8. Systemic steroids or other immunosuppressants medication
9. Principal investigator determines that the case is Inappropriate to register for this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takehiro
Middle name
Last name Matsuda
Organization Okinawa prefectural Nanbu Medical Center, Children's Medical Center
Division name Division of Pediatric Hematology and Oncology
Zip code 9011193
Address 118-1 Arakawa, Haebaru-chou, Shimajiri-gun, Okinawa 901-1193, Japan
TEL 098-888-0123
Email takehiro.matsuda@nifty.com

Public contact
Name of contact person
1st name Takehiro
Middle name
Last name Matsuda
Organization Okinawa prefectural Nanbu Medical Center, Children's Medical Center
Division name Division of Pediatric Hematology and Oncology
Zip code 9011193
Address 118-1 Arakawa, Haebaru-chou, Shimajiri-gun, Okinawa 901-1193, Japan
TEL 098-888-0123
Homepage URL
Email takehiro.matsuda@nifty.com

Sponsor
Institute Group for "combination chemotherapies for refractory Adolescent and Young Adult solid tumors "
Institute
Department

Funding Source
Organization Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization No
Address No
Tel 0988880123
Email chinamsr@pref.okinawa.lg.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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 11 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 10
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 Terminated
Date of protocol fixation
2015 Year 09 Month 10 Day
Date of IRB
2015 Year 06 Month 02 Day
Anticipated trial start date
2015 Year 12 Month 11 Day
Last follow-up date
2019 Year 02 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 10 Day
Last modified on
2020 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023239

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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