UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020144 |
|---|---|
| Receipt number | 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 13:49:27 |
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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
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
takehiro.matsuda@nifty.com
Sponsor or person
Institute
Group for "combination chemotherapies for refractory Adolescent and Young Adult solid tumors "
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023239
