ID
44154
Beschrijving
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
Trefwoorden
Versies (5)
- 26-12-17 26-12-17 -
- 27-12-17 27-12-17 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
- 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
- 20-09-21 20-09-21 -
Houder van rechten
Universität zu Köln
Geüploaded op
20 september 2021
DOI
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Licentie
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
Beschrijving
Referenzradiologie MRT/CT
Beschrijving
Examination date
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Method
Datatype
integer
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Quality
Datatype
integer
Alias
- UMLS CUI [1]
- C0332306
Beschrijving
Primary tumor
Datatype
integer
Alias
- UMLS CUI [1]
- C0677930
Beschrijving
tumor height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C1301092
Beschrijving
Neoplasms Width
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0487742
- UMLS CUI [1,2]
- C0027651
Beschrijving
Tumor length
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1444754
Beschrijving
Target sum
Datatype
integer
Alias
- UMLS CUI [1]
- C1515051
Beschrijving
Contrast Media
Datatype
boolean
Alias
- UMLS CUI [1]
- C0807938
Beschrijving
Neoplasm Metastasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027627
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0346979
Beschrijving
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0686619
Beschrijving
Number of lymph nodes involved by malignant neoplasm
Datatype
integer
Alias
- UMLS CUI [1]
- C2732750
Beschrijving
Secondary malignant neoplasm of liver
Datatype
boolean
Alias
- UMLS CUI [1]
- C0494165
Beschrijving
Quanity metastasis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0027627
Beschrijving
Skin
Datatype
boolean
Alias
- UMLS CUI [1]
- C1123023
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C3714787
Beschrijving
Other
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
Referenzbeurteilung mIBG
Beschrijving
Examination date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Diagnostic Imaging
Datatype
integer
Alias
- UMLS CUI [1]
- C0011923
Beschrijving
3-Iodobenzylguanidine Neoplasm Metastasis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Beschrijving
signal intensity; primary tumor
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0871362
- UMLS CUI [1,2]
- C0677930
Beschrijving
primary tumor image
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0005891
Beschrijving
3-Iodobenzylguanidine neoplasm metastasis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Beschrijving
Bone marrow metastasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0346979
Beschrijving
Score
Datatype
integer
Alias
- UMLS CUI [1]
- C0449820
Beschrijving
Liver finding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0426686
Beschrijving
Soft Tissue Injuries
Datatype
boolean
Alias
- UMLS CUI [1]
- C0037578
Beschrijving
Neuroblastoma Score
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027819
- UMLS CUI [1,2]
- C0449820
Beschrijving
Referenzbeurteilung Knochenmark
Beschrijving
Bone Marrow Examination Date
Datatype
integer
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C2826643
Beschrijving
Cytology procedure
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305671
Beschrijving
Bone marrow infiltration
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854434
- UMLS CUI [1,2]
- C0010819
- UMLS CUI [1,3]
- C0332448
Beschrijving
Immunocytochemistry
Datatype
boolean
Alias
- UMLS CUI [1]
- C0242349
Beschrijving
Immunocytochemistry Bone marrow infiltration
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0242349
- UMLS CUI [1,2]
- C3854434
Beschrijving
PCR
Datatype
boolean
Beschrijving
Polymerase Chain Reaction
Datatype
integer
Alias
- UMLS CUI [1]
- C0032520
Beschrijving
Polymerase Chain Reaction Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C0947611
Beschrijving
Sonstige Untersuchungen
Beschrijving
Examination Date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Examination by method To specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Beschrijving
primary tumor
Datatype
integer
Alias
- UMLS CUI [1]
- C0677930
Beschrijving
Secondary malignant neoplasm of bone
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Beschrijving
Finding Distant Lymph Node
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C3830456
Beschrijving
Liver finding
Datatype
integer
Alias
- UMLS CUI [1]
- C0426686
Beschrijving
Skin finding
Datatype
integer
Alias
- UMLS CUI [1]
- C0455205
Beschrijving
Central Nervous System Finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Beschrijving
Neoplasm Metastasis Other
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C1335151
Beschrijving
Neoplasm Metastasis Other
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
Beschrijving
Homovanillic acid measurement; Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C1274040
Beschrijving
Gesamtbeurteilung
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1]
- C1704632
Beschrijving
Disease status mIBG
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0047506
Beschrijving
Disease status Contrast Media
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0009924
Beschrijving
Sum
Datatype
integer
Alias
- UMLS CUI [1]
- C1515051
Beschrijving
Disease remission Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Beschrijving
Tumor marker
Beschrijving
Neuron specific enolase measurement
Datatype
integer
Maateenheden
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Beschrijving
NSE result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202144
- UMLS CUI [1,2]
- C1274040
Beschrijving
LDH
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
Lactate dehydrogenase measurement result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C1274040
Beschrijving
Urine VMA level result
Datatype
integer
Maateenheden
- mg/g
Alias
- UMLS CUI [1]
- C1261438
Beschrijving
Age-dependent penetrance; vanilmandelic acid; Factor
Datatype
text
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Beschrijving
Urine VMA level result
Datatype
integer
Alias
- UMLS CUI [1]
- C1261438
Beschrijving
HVA
Datatype
integer
Maateenheden
- mg/g
Alias
- UMLS CUI [1]
- C0202071
Beschrijving
Age-dependent penetrance; Factor; Homovanillic acid measurement
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Beschrijving
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])