ID
44154
Descripción
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
Palabras clave
Versiones (5)
- 26/12/17 26/12/17 -
- 27/12/17 27/12/17 -
- 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
- 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
- 20/9/21 20/9/21 -
Titular de derechos de autor
Universität zu Köln
Subido en
20 de septiembre de 2021
DOI
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Licencia
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
Descripción
Referenzradiologie MRT/CT
Descripción
Examination date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826643
Descripción
Method
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2911685
Descripción
Quality
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0332306
Descripción
Primary tumor
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0677930
Descripción
tumor height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C1301092
Descripción
Neoplasms Width
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1,1]
- C0487742
- UMLS CUI [1,2]
- C0027651
Descripción
Tumor length
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1444754
Descripción
Target sum
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1515051
Descripción
Contrast Media
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0807938
Descripción
Neoplasm Metastasis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0027627
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0346979
Descripción
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0686619
Descripción
Number of lymph nodes involved by malignant neoplasm
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2732750
Descripción
Secondary malignant neoplasm of liver
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0494165
Descripción
Quanity metastasis
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0027627
Descripción
Skin
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1123023
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3714787
Descripción
Other
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0205394
Descripción
Referenzbeurteilung mIBG
Descripción
Examination date
Tipo de datos
date
Unidades de medida
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Descripción
Diagnostic Imaging
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0011923
Descripción
3-Iodobenzylguanidine Neoplasm Metastasis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Descripción
signal intensity; primary tumor
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0871362
- UMLS CUI [1,2]
- C0677930
Descripción
primary tumor image
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0005891
Descripción
3-Iodobenzylguanidine neoplasm metastasis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0047506
- UMLS CUI [1,2]
- C0027627
Descripción
Bone marrow metastasis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0346979
Descripción
Score
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0449820
Descripción
Liver finding
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0426686
Descripción
Soft Tissue Injuries
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0037578
Descripción
Neuroblastoma Score
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027819
- UMLS CUI [1,2]
- C0449820
Descripción
Referenzbeurteilung Knochenmark
Descripción
Bone Marrow Examination Date
Tipo de datos
integer
Unidades de medida
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C2826643
Descripción
Cytology procedure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1305671
Descripción
Bone marrow infiltration
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854434
- UMLS CUI [1,2]
- C0010819
- UMLS CUI [1,3]
- C0332448
Descripción
Immunocytochemistry
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0242349
Descripción
Immunocytochemistry Bone marrow infiltration
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0242349
- UMLS CUI [1,2]
- C3854434
Descripción
PCR
Tipo de datos
boolean
Descripción
Polymerase Chain Reaction
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0032520
Descripción
Polymerase Chain Reaction Comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C0947611
Descripción
Sonstige Untersuchungen
Descripción
Examination Date
Tipo de datos
date
Unidades de medida
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Descripción
Examination by method To specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Descripción
primary tumor
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0677930
Descripción
Secondary malignant neoplasm of bone
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Descripción
Finding Distant Lymph Node
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C3830456
Descripción
Liver finding
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0426686
Descripción
Skin finding
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0455205
Descripción
Central Nervous System Finding
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Descripción
Neoplasm Metastasis Other
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C1335151
Descripción
Neoplasm Metastasis Other
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
Descripción
Homovanillic acid measurement; Result
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C1274040
Descripción
Gesamtbeurteilung
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1704632
Descripción
Disease status mIBG
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0047506
Descripción
Disease status Contrast Media
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704632
- UMLS CUI [1,2]
- C0009924
Descripción
Sum
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1515051
Descripción
Disease remission Status
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Descripción
Tumor marker
Descripción
Neuron specific enolase measurement
Tipo de datos
integer
Unidades de medida
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Descripción
NSE result
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202144
- UMLS CUI [1,2]
- C1274040
Descripción
LDH
Tipo de datos
integer
Unidades de medida
- U/L
Alias
- UMLS CUI [1]
- C0202113
Descripción
Lactate dehydrogenase measurement result
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C1274040
Descripción
Urine VMA level result
Tipo de datos
integer
Unidades de medida
- mg/g
Alias
- UMLS CUI [1]
- C1261438
Descripción
Age-dependent penetrance; vanilmandelic acid; Factor
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Descripción
Urine VMA level result
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1261438
Descripción
HVA
Tipo de datos
integer
Unidades de medida
- mg/g
Alias
- UMLS CUI [1]
- C0202071
Descripción
Age-dependent penetrance; Factor; Homovanillic acid measurement
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Descripción
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])