UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000023239