ID
44154
Beskrivning
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
Nyckelord
Versioner (5)
- 2017-12-26 2017-12-26 -
- 2017-12-27 2017-12-27 -
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
- 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
- 2021-09-20 2021-09-20 -
Rättsinnehavare
Universität zu Köln
Uppladdad den
20 september 2021
DOI
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Licens
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
Relapse
- 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
Beskrivning
Referenzradiologie MRT/CT
Beskrivning
Examination date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Method
Datatyp
integer
Alias
- UMLS CUI [1]
- C2911685
Beskrivning
Quality
Datatyp
integer
Alias
- UMLS CUI [1]
- C0332306
Beskrivning
Primary tumor
Datatyp
integer
Alias
- UMLS CUI [1]
- C0677930
Beskrivning
tumor height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C1301092
Beskrivning
Neoplasms Width
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1,1]
- C0487742
- UMLS CUI [1,2]
- C0027651
Beskrivning
Tumor length
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1444754
Beskrivning
Target sum
Datatyp
integer
Alias
- UMLS CUI [1]
- C1515051
Beskrivning
Contrast Media
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0807938
Beskrivning
Neoplasm Metastasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0027627
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0346979
Beskrivning
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0686619
Beskrivning
Number of lymph nodes involved by malignant neoplasm
Datatyp
integer
Alias
- UMLS CUI [1]
- C2732750
Beskrivning
Secondary malignant neoplasm of liver
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0494165
Beskrivning
Quanity metastasis
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0027627
Beskrivning
Skin
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1123023
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3714787
Beskrivning
Other
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205394
Beskrivning
Referenzbeurteilung mIBG
Beskrivning
Examination date
Datatyp
date
Måttenheter
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Diagnostic Imaging
Datatyp
integer
Alias
- UMLS CUI [1]
- C0011923
Beskrivning
3-Iodobenzylguanidine Neoplasm Metastasis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Beskrivning
signal intensity; primary tumor
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0871362
- UMLS CUI [1,2]
- C0677930
Beskrivning
primary tumor image
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0005891
Beskrivning
3-Iodobenzylguanidine neoplasm metastasis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Beskrivning
Bone marrow metastasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0346979
Beskrivning
Score
Datatyp
integer
Alias
- UMLS CUI [1]
- C0449820
Beskrivning
Liver finding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0426686
Beskrivning
Soft Tissue Injuries
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0037578
Beskrivning
Neuroblastoma Score
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027819
- UMLS CUI [1,2]
- C0449820
Beskrivning
Referenzbeurteilung Knochenmark
Beskrivning
Bone Marrow Examination Date
Datatyp
integer
Måttenheter
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C2826643
Beskrivning
Cytology procedure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1305671
Beskrivning
Bone marrow infiltration
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854434
- UMLS CUI [1,2]
- C0010819
- UMLS CUI [1,3]
- C0332448
Beskrivning
Immunocytochemistry
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0242349
Beskrivning
Immunocytochemistry Bone marrow infiltration
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0242349
- UMLS CUI [1,2]
- C3854434
Beskrivning
PCR
Datatyp
boolean
Beskrivning
Polymerase Chain Reaction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0032520
Beskrivning
Polymerase Chain Reaction Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C0947611
Beskrivning
Sonstige Untersuchungen
Beskrivning
Examination Date
Datatyp
date
Måttenheter
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Examination by method To specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Beskrivning
primary tumor
Datatyp
integer
Alias
- UMLS CUI [1]
- C0677930
Beskrivning
Secondary malignant neoplasm of bone
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Beskrivning
Finding Distant Lymph Node
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C3830456
Beskrivning
Liver finding
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426686
Beskrivning
Skin finding
Datatyp
integer
Alias
- UMLS CUI [1]
- C0455205
Beskrivning
Central Nervous System Finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Beskrivning
Neoplasm Metastasis Other
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C1335151
Beskrivning
Neoplasm Metastasis Other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
Beskrivning
Homovanillic acid measurement; Result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C1274040
Beskrivning
Gesamtbeurteilung
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1]
- C1704632
Beskrivning
Disease status mIBG
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0047506
Beskrivning
Disease status Contrast Media
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0009924
Beskrivning
Sum
Datatyp
integer
Alias
- UMLS CUI [1]
- C1515051
Beskrivning
Disease remission Status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Beskrivning
Tumor marker
Beskrivning
Neuron specific enolase measurement
Datatyp
integer
Måttenheter
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Beskrivning
NSE result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0202144
- UMLS CUI [1,2]
- C1274040
Beskrivning
LDH
Datatyp
integer
Måttenheter
- U/L
Alias
- UMLS CUI [1]
- C0202113
Beskrivning
Lactate dehydrogenase measurement result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C1274040
Beskrivning
Urine VMA level result
Datatyp
integer
Måttenheter
- mg/g
Alias
- UMLS CUI [1]
- C1261438
Beskrivning
Age-dependent penetrance; vanilmandelic acid; Factor
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Beskrivning
Urine VMA level result
Datatyp
integer
Alias
- UMLS CUI [1]
- C1261438
Beskrivning
HVA
Datatyp
integer
Måttenheter
- mg/g
Alias
- UMLS CUI [1]
- C0202071
Beskrivning
Age-dependent penetrance; Factor; Homovanillic acid measurement
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Beskrivning
Fußzeile
Similar models
Relapse
- 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
C0040405 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0684336 (UMLS CUI-2)
(Comment:de)
(Comment:de)
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])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
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])
C1274040 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0047506 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0009924 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0449438 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C1274040 (UMLS CUI [1,2])
C0042317 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
C1521761 (UMLS CUI [1,2])
C0202071 (UMLS CUI [1,3])