ID
44154
Description
NCT02641314 Phase 2 Trial of Metronomic Treatment in Children and Adolescents With Recurrent or Progressive Neuroblastoma (NB). The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected. Prof. Dr. Frank Berthold Abt. für Kinderonkologie und –hämatologie Zentrum für Kinder- und Jugendmedizin Universität zu Köln
Keywords
Versions (5)
- 12/26/17 12/26/17 -
- 12/27/17 12/27/17 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
Universität zu Köln
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314
Reference
- StudyEvent: Subject Protocol
- Registration
- Medical history
- Baseline
- Therapy and toxicity cycle 1-3
- Therapy and toxicity cycle 4-6
- Therapy and toxicity cycle 7-9
- Therapy and toxicity cycle 10-13
- Therapy and toxicity cycle > 13
- Reference
- Study relevant visits
- Therapeutic response
- End of therapy
- Relapse
- Second malignancy
- Death
- Follow up
Description
Referenzbeurteilung mIBG
Description
mIBG
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0011008
Description
Quality
Data type
integer
Alias
- UMLS CUI [1]
- C0332306
Description
mIBG
Data type
integer
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0677930
Description
signal intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0871362
- UMLS CUI [1,2]
- C0677930
Description
Image quality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0005891
Description
mIBG Metastasis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Description
Neoplasm Metastasis of bone marrow
Data type
boolean
Alias
- UMLS CUI [1]
- C0346979
Description
Score
Data type
integer
Alias
- UMLS CUI [1]
- C0449820
Description
liver metatsis
Data type
boolean
Alias
- UMLS CUI [1]
- C0426686
Description
Soft tissue
Data type
boolean
Alias
- UMLS CUI [1]
- C0037578
Description
SIOPEN Score
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027819
- UMLS CUI [1,2]
- C0449820
Description
Referenzbeurteilung Knochenmark
Description
Bone marrow Examination Date
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C2826643
Description
Cytology
Data type
boolean
Alias
- UMLS CUI [1]
- C1305671
Description
Cytology bone marrow Infiltration
Data type
text
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C3854434
- UMLS CUI [1,2]
- C0010819
- UMLS CUI [1,3]
- C0332448
Description
Immunocytochemistry
Data type
boolean
Alias
- UMLS CUI [1]
- C0242349
Description
Immunocytochemistry Bone marrow infiltration
Data type
integer
Alias
- UMLS CUI [1,1]
- C0242349
- UMLS CUI [1,2]
- C3854434
Description
PCR
Data type
boolean
Alias
- UMLS CUI [1]
- C0032520
Description
PCR test result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C0032520
Description
PCR test result comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C0032520
- UMLS CUI [1,3]
- C0947611
Description
Sonstige Untersuchungen
Description
Examination date other method
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Description
Examination method
Data type
text
Alias
- UMLS CUI [1]
- C1282548
Description
primary tumor
Data type
integer
Alias
- UMLS CUI [1]
- C0677930
Description
Secondary malignant neoplasm of bone; Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Description
Secondary malignant neoplasm of lymph node
Data type
integer
Alias
- UMLS CUI [1]
- C0686619
Description
Liver finding
Data type
integer
Alias
- UMLS CUI [1]
- C0426686
Description
Skin finding
Data type
integer
Alias
- UMLS CUI [1]
- C0455205
Description
Central Nervous System; Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Description
Neoplasm Metastasis other Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1335151
Description
Specify other neoplasm metastasis
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Description
Gesamtbeurteilung
Description
CR: Komplette Remission
Data type
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Description
If no CR
Data type
integer
Alias
- UMLS CUI [1]
- C3844738
Description
Target sum
Data type
integer
Alias
- UMLS CUI [1]
- C1515051
Description
Zeitpunkt des Stagings
Description
Time of staging
Data type
integer
Alias
- UMLS CUI [1]
- C0040223
Description
Time other
Data type
text
Alias
- UMLS CUI [1]
- C0040223
Description
MRT / CT
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024485
- UMLS CUI [1,2]
- C0040405
Description
3-Iodobenzylguanidine
Data type
boolean
Alias
- UMLS CUI [1]
- C0047506
Description
Bone Marrow Examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0005957
Description
Other specified examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0260879
Description
Referenzradiologie MRT/CT
Description
Examination date
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Method
Data type
integer
Alias
- UMLS CUI [1]
- C2911685
Description
Quality
Data type
integer
Alias
- UMLS CUI [1]
- C0332306
Description
Primary tumor
Data type
integer
Alias
- UMLS CUI [1]
- C0677930
Description
tumor height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C1301092
Description
Neoplasms Width
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0487742
- UMLS CUI [1,2]
- C0027651
Description
Tumor length
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1444754
Description
Target sum
Data type
integer
Alias
- UMLS CUI [1]
- C1515051
Description
Contrast Media
Data type
boolean
Alias
- UMLS CUI [1]
- C0807938
Description
Neoplasm Metastasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0027627
Description
Osteomedullärer Befall definiert als zytologischer Knochnemark-Befall und/oder szintigraphischer Nachweis eines osteomedullären Befalls und/oder Osteolysen (Röntgen oder CT). Alleinige Knochenmark-Auffälligkeiten in der Kernspintomographien werden nicht als osteomedullärer Befall gewertet.
Data type
boolean
Alias
- UMLS CUI [1]
- C0346979
Description
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Data type
boolean
Alias
- UMLS CUI [1]
- C0686619
Description
Number of lymph nodes involved by malignant neoplasm
Data type
integer
Alias
- UMLS CUI [1]
- C2732750
Description
Secondary malignant neoplasm of liver
Data type
boolean
Alias
- UMLS CUI [1]
- C0494165
Description
Quanity metastasis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0027627
Description
Skin
Data type
boolean
Alias
- UMLS CUI [1]
- C1123023
Description
ZNS-Metastasen sind definiert als intrazerebrale Parenchym-Herde, rein intraspinale Parenchym-Herde oder leptomeningeale Metastasen. Nicht als ZNS-Befall gewertet wird eine Mitbeteiligung der Dura bei osteomedullärer Metastasierung des angrenzenden Knochens
Data type
boolean
Alias
- UMLS CUI [1]
- C3714787
Description
Other
Data type
boolean
Alias
- UMLS CUI [1]
- C0205394
Description
Referenzbeurteilung mIBG
Description
Examination date
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Description
Diagnostic Imaging
Data type
integer
Alias
- UMLS CUI [1]
- C0011923
Description
3-Iodobenzylguanidine Neoplasm Metastasis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Description
signal intensity; primary tumor
Data type
integer
Alias
- UMLS CUI [1,1]
- C0871362
- UMLS CUI [1,2]
- C0677930
Description
primary tumor image
Data type
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0005891
Description
3-Iodobenzylguanidine neoplasm metastasis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Description
Bone marrow metastasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0346979
Description
Score
Data type
integer
Alias
- UMLS CUI [1]
- C0449820
Description
Liver finding
Data type
boolean
Alias
- UMLS CUI [1]
- C0426686
Description
Soft Tissue Injuries
Data type
boolean
Alias
- UMLS CUI [1]
- C0037578
Description
Neuroblastoma Score
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027819
- UMLS CUI [1,2]
- C0449820
Description
Referenzbeurteilung Knochenmark
Description
Bone Marrow Examination Date
Data type
integer
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C2826643
Description
Cytology procedure
Data type
boolean
Alias
- UMLS CUI [1]
- C1305671
Description
Bone marrow infiltration
Data type
integer
Alias
- UMLS CUI [1,1]
- C3854434
- UMLS CUI [1,2]
- C0010819
- UMLS CUI [1,3]
- C0332448
Description
Immunocytochemistry
Data type
boolean
Alias
- UMLS CUI [1]
- C0242349
Description
Immunocytochemistry Bone marrow infiltration
Data type
integer
Alias
- UMLS CUI [1,1]
- C0242349
- UMLS CUI [1,2]
- C3854434
Description
PCR
Data type
boolean
Description
Polymerase Chain Reaction
Data type
integer
Alias
- UMLS CUI [1]
- C0032520
Description
Polymerase Chain Reaction Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C0947611
Description
Sonstige Untersuchungen
Description
Examination Date
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Description
Examination by method To specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Description
primary tumor
Data type
integer
Alias
- UMLS CUI [1]
- C0677930
Description
Secondary malignant neoplasm of bone
Data type
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Description
Finding Distant Lymph Node
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C3830456
Description
Liver finding
Data type
integer
Alias
- UMLS CUI [1]
- C0426686
Description
Skin finding
Data type
integer
Alias
- UMLS CUI [1]
- C0455205
Description
Central Nervous System Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Description
Neoplasm Metastasis Other
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C1335151
Description
Neoplasm Metastasis Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
Description
Gesamtbeurteilung
Description
CR: Verschwinden aller Tumor-Target- und Non-Target-Läsionen. Größenreduktion pathologischer Lymphknoten in der kurzen Achse auf < 10 mm; Tumormarker normalisiert PR: ≥ 30% Abnahme der Summe der Durchmesser der Tumor-Target-Läsionen (im Vergleich zum Ausgang (baseline), Non-Tumor-Target-Läsionen können noch vorhanden sein und/oder: Tumormarker oberhalb der Normalwerte SD: Weder PR oder PD Referenz: Summe der jeweils kürzesten Durchmesser im Vergleich zum Ausgang (baseline) oder während der Studie. PD: ≥ 20% Zunahme der Summe der jeweils kürzesten Durchmesser im Vergleich zum Ausgang (baseline) oder während der Studie. Die Zunahme muss mindestens 5mm betragen. und/oder Auftreten einer neuen Tumorläsion und/oder Existierende Non-Target-Tumor-Läsion(en) sind eindeutig progredient
Data type
integer
Alias
- UMLS CUI [1]
- C1704632
Description
Disease status mIBG
Data type
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0047506
Description
Disease status Contrast Media
Data type
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0009924
Description
Sum
Data type
integer
Alias
- UMLS CUI [1]
- C1515051
Description
Disease remission Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Description
Fußzeile
Similar models
Reference
- StudyEvent: Subject Protocol
- Registration
- Medical history
- Baseline
- Therapy and toxicity cycle 1-3
- Therapy and toxicity cycle 4-6
- Therapy and toxicity cycle 7-9
- Therapy and toxicity cycle 10-13
- Therapy and toxicity cycle > 13
- Reference
- Study relevant visits
- Therapeutic response
- End of therapy
- Relapse
- Second malignancy
- Death
- Follow up
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C0205394 (UMLS CUI [1,2])
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C0027651 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,2])
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C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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C0677930 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
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C0027627 (UMLS CUI [1,2])
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C0449820 (UMLS CUI [1,2])
C2826643 (UMLS CUI [1,2])
C0010819 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C3854434 (UMLS CUI [1,2])
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C0032520 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1335151 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,2])
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C0040405 (UMLS CUI [1,2])
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C0684336 (UMLS CUI-2)
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C0027651 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
C0005891 (UMLS CUI [1,2])
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C0027627 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C2826643 (UMLS CUI [1,2])
C0010819 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C3854434 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C3830456 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C1335151 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
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C0047506 (UMLS CUI [1,2])
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C0009924 (UMLS CUI [1,2])
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C0449438 (UMLS CUI [1,2])
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