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