UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023009 |
|---|---|
| Receipt number | R000026438 |
| Scientific Title | Phase 2b study of combined immunotherapy with dinutuximab, interleukin-2, and G-CSF for high risk neuroblastoma |
| Date of disclosure of the study information | 2016/07/04 |
| Last modified on | 2020/02/04 22:37:37 |
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Basic information
Public title
Phase 2b study of combined immunotherapy with dinutuximab, interleukin-2, and G-CSF for high risk neuroblastoma
Acronym
GD2-P2
Scientific Title
Phase 2b study of combined immunotherapy with dinutuximab, interleukin-2, and G-CSF for high risk neuroblastoma
Scientific Title:Acronym
GD2-P2
Region
| Japan |
Condition
Condition
high risk neuroblastoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effiicacy of Japan regimen (G therapy) combining dinutuximab, teceleukin and filgrastim, compared to the US regimen combining dinutuximab, aldesleukin, sargramositim and isotretinoin as maintenance therapy for high risk neuroblastoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-year event free survival
Key secondary outcomes
1. Overall-survival, response rate and progression-free survival
2. Adverse event of G therapy and US regimen
3. ADCC activity in G therapy and US regimen
4. Production rate of human anti-chimeric antibody (HACA)
5. Pharmacokinetics of isotretinoin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
G therapy: Six courses of G therapy CSF regimen and G therapy IL2 regimen alternately.
1. G therapy CSF regimen
Subcutaneous injection of filgrastim 5 mcrg / kg from day 1 to day 14.
Intravenous administration of dinutuximab 17.5 mg / m2 from day 4 to day 7.
2. G therapy IL2 regimen
Intravenous administration of teceleukin 75 MU / m2 from day 1 to day 4 and from day 8 to day 11
Intravenous administration of dinutuximab 17.5 mg / m2 from day 4 to day 7
Interventions/Control_2
US regimen: Five courses of US CSF regimen and US IL2 regimen alternately then one course of isotretinoin alone.
1. US CSF regimen
Subcutaneous injection of sargramostim 250 mcrg / kg from day 1 to day 14.
Intravenous administration of dinutuximab 17.5 mg / m2 from day 4 to day 7.
Orally 160 mg/m2 (BW >12 kg) or 5.33 mg/kg (BW <=12 kg) isotretionoin from day 11 to day 24
2. US IL2 regimen
Intravenous administration of aldesleukin 300 MU / m2 from day 1 to day 4 and from day 8 to day 11
Intravenous administration of dinutuximab 17.5 mg / m2 from day 4 to day 7
Orally 160 mg/m2 (BW >12 kg) or 5.33 mg/kg (BW <=12 kg) isotretionoin from day 11 to day 24
3. Isotretinoin regimen
Orally 160 mg/m2 (BW >12 kg) or 5.33 mg/kg (BW <=12 kg) isotretionoin from day 11 to day 24
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
| Not applicable |
Age-upper limit
| 31 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy.
2. No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT.
3. At pre-ASCT evaluation patients must meet the INRC for CR, VGPR, or PR for any region.
4. For those with residual disease after operation, re-evaluation of irradiated residual tumors is performed at the earliest 5 days after completing radiotherapy.
5. <= 10% tumor seen on any specimen from a bone marrow aspirate/biopsy.
6. Patients must be enrolled no later than Day 100 after PBSC infusion. However, in the cases with surgery followed by autologous peripheral blood transfusion, allowing less than 150 days from autologous peripheral blood stem cell infusion.
7. Patients must not have received prior anti-GD2 antibody therapy.
8. Patients must have a Lansky or Karnofsky Performance Scale score of >= 50%.
9. Patient must have adequate organ function.
Key exclusion criteria
1. Synchronous or asynchronous (within 5 years) other cancer except carcinoma in situ or intramucosal carcinoma.
2. Active infection requires systemic therapy.
3. Epileptic seizures without control by anticonvulsants
4. Daily use of a steroid
5. Administration of immune globulin within 28 days
6. Abnormalities of ECG requires therapy.
7. Less than 30% of Fractional Shortening and less than 55% of Ejection Fraction in cardiac function within 28 days
There is respiratory failure requiring 8. oxygen administration
9. Woman during pregnancy, or impossible to discontinue breast-feeding for 120 days after the final dose of study treatment.
10. Patient or the partner without intent to use birth control.
11. Inadequate physical condition judged by investigator.
12. Known investigational drugs allergy.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hara |
Organization
Osaka City General Hospital
Division name
Department of Pediatric Hematology/Oncology
Zip code
5340021
Address
2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
j-hara@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Nitani |
Organization
Osaka City General Hospital
Division name
Department of Pediatric Hematology/Oncology
Zip code
5340021
Address
2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
Homepage URL
c-tanaka@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of Osaka City General Hospital
Address
2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
Tel
06-6929-1221
c-tanaka@med.osakacity-hp.or.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
大阪市立総合医療センター（大阪府）、北海道大学病院（北海道）、九州大学病院（福岡県）、広島大学病院（広島県）、成育医療研究センター（東京都）、東京都立小児医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 04 | 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
35
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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026438
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