ID
42136
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
13 april 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
Baseline
- 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
Kardiologische Untersuchungen
Alias
- UMLS CUI-1
- C0007189
- UMLS CUI-2
- C0031809
Beschrijving
Date of Echocardiography
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013516
Beschrijving
Cardiac ejection fraction
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0232174
Beschrijving
Electrocardiography date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Beschrijving
ECG finding
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
ECG abnormal reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0362082
Beschrijving
Findings sent to patient?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C1519246
Beschrijving
Laboruntersuchungen
Beschrijving
White Blood Cell Count
Datatype
integer
Maateenheden
- Mikroliter
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Absolute neutrophil count
Datatype
integer
Maateenheden
- yL
Alias
- UMLS CUI [1]
- C0948762
Beschrijving
Hemoglobin
Datatype
integer
Maateenheden
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Blood Platelets
Datatype
integer
Maateenheden
- yL
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
Glucose measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0337438
Beschrijving
Tumormarker
Beschrijving
NSE
Datatype
integer
Maateenheden
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Beschrijving
NSE result
Datatype
integer
Alias
- UMLS CUI [1]
- C0202144
Beschrijving
LDH
Datatype
integer
Maateenheden
- U/l
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
LDH result
Datatype
integer
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
Urine VMA level result
Datatype
integer
Maateenheden
- mg/g Crea
Alias
- UMLS CUI [1]
- C1261438
Beschrijving
Unit vma
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1261438
- UMLS CUI [1,2]
- C1519795
Beschrijving
age dependent vma factor
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Beschrijving
vma result
Datatype
integer
Alias
- UMLS CUI [1]
- C1261438
Beschrijving
homovanillic acid
Datatype
integer
Maateenheden
- mg/g Crea
Alias
- UMLS CUI [1]
- C0202071
Beschrijving
homovanillic acid unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C0439148
Beschrijving
age dependent factor
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Beschrijving
Homovanillic acid measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202071
Beschrijving
Surrogatmarker
Beschrijving
Immunophenotyping
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079611
Beschrijving
Collection of blood specimen for laboratory procedure date in time
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Shipping
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C1524049
- UMLS CUI [1,3]
- C0011008
Beschrijving
Lebensqualität
Beschrijving
Bildgebung
Alias
- UMLS CUI-1
- C0011923
Beschrijving
MRT / CT
Datatype
boolean
Alias
- UMLS CUI [1]
- C0024485
- UMLS CUI [2]
- C0040405
Beschrijving
mIBG
Datatype
boolean
Alias
- UMLS CUI [1]
- C0047506
Beschrijving
Bone Marrow Examination
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005957
Beschrijving
Other examination?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
Beschrijving
Specify other examination
Datatype
text
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschrijving
Lokale MRT/CT Beurteilung
Beschrijving
MRT Untersuchungen werden bevorzugt
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0024485
Beschrijving
Evaluation method
Datatype
integer
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Anatomic site
Datatype
integer
Alias
- UMLS CUI [1]
- C1515974
Beschrijving
Primary tumor
Datatype
integer
Alias
- UMLS CUI [1]
- C0677930
Beschrijving
Status of distant metastasis
Datatype
integer
Alias
- UMLS CUI [1]
- C1302548
Beschrijving
Osteomedullärer Befall hier definiert als zytologischer Knochenmark-Befall und/oder szintigraphischer Nachweis und/oder radiologischer Nachweis (Röntgen oder CT). Nicht-Kontrastmittel aufnehmende Knochenmark-Veränderungen allein im MRT Kernspintomographien werden nicht als osteomedullärer Befall gewertet.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0153690
- UMLS CUI [2]
- C0346979
Beschrijving
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3830456
- UMLS CUI [1,2]
- C2939420
- UMLS CUI [1,3]
- C0024485
Beschrijving
Secondary malignant neoplasm of liver
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0024485
Beschrijving
Secondary malignant neoplasm of skin
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0153687
- UMLS CUI [1,2]
- C0024485
Beschrijving
ZNS-Metastasen sind definiert als intrazerebrale Parenchym-Herde, rein intraspinale Parenchym-Herde oder diffuse leptomeningeale Metastasen. Nicht als ZNS-Befall gewertet wird eine regionale Mitbeteiligung der Dura bei osteomedullärer Metastasierung des angrenzenden Knochens.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0686377
Beschrijving
Neoplasm Metastasis; Other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
Beschrijving
Specify other neoplasm metastasis
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Beschrijving
Lokale MRT/CT Beurteilung
Beschrijving
Lokale mIBG-Beurteilung
Alias
- UMLS CUI-1
- C2229074
Beschrijving
MIBG scintiscan date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0011008
Beschrijving
MIBG Finding primary tumor
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0677930
Beschrijving
mIBG findings metastasis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C4255448
Beschrijving
MIBG scintiscan findings sent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C1519246
- UMLS CUI [1,3]
- C0220825
Beschrijving
Knochenmarkuntersuchungen
Alias
- UMLS CUI-1
- C0005957
Beschrijving
Method Bone Marrow Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0005957
Beschrijving
Bone marrow biopsy date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Beschrijving
Bone marrow sent?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514873
- UMLS CUI [1,2]
- C0520510
- UMLS CUI [1,3]
- C1524049
- UMLS CUI [1,4]
- C0005953
- UMLS CUI [1,5]
- C0005767
Beschrijving
Sonstige Untersuchungen
Alias
- UMLS CUI-1
- C0260879
Beschrijving
Examination date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Specimen sent?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519246
Beschrijving
Examination method specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Beschrijving
Finding primary tumor
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0677930
Beschrijving
Findings bone metastases
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
Finding CNS
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Beschrijving
Finding other metastases
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1335151
Beschrijving
Other Metastasis specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Beschrijving
Gesamtbeurteilung
Beschrijving
CR: Kein Primärtumor und keine Metastasen nachweisbar, Katecholamine normal VGPR: Primärtumor-Reduktion um 90-99%. Keine Metastasen nachweisbar, Katecholamine normal, Nachweis von Resten bei Knochenszintigrafie erlaubt PR: Primärtumor-Reduktion um >50%, Alle messbaren Metastasen haben sich um >50% reduziert. Knochen und KM: Knochenbefall hat sich um >50% reduziert; nicht mehr als 1 positiver KM-Befund erlaubt (muss einer Abnahme in der Anzahl an positiven Befunden im Vergleich zur Diagnose entsprechen) SD: Keine neuen Läsionen nachweisbar; PD: Nachweis einer neuen Läsionen und/oder Zunahme einer messbaren Läsionen um >25%; vorangegangenes negatives Knochenmark wird Tumor-positiv
Datatype
text
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0432510
Beschrijving
Date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
Baseline
- 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
C0206065 (UMLS CUI [2])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0013516 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0362082 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0205307 (UMLS CUI-2)
(Comment:de)
C0205161 (UMLS CUI-2)
(Comment:de)
(Comment:de)
(Comment:de)
C1519795 (UMLS CUI [1,2])
C0042317 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
(Comment:de)
C0205161 (UMLS CUI-2)
(Comment:de)
C0439148 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,2])
C0202071 (UMLS CUI [1,3])
C0086715 (UMLS CUI-2)
(Comment:de)
C0205161 (UMLS CUI-2)
(Comment:de)
C0011008 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0034380 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C1275402 (UMLS CUI-2)
(Comment:de)
C0346979 (UMLS CUI [2])
C2939420 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
C0243095 (UMLS CUI [1,2])
C4255448 (UMLS CUI [1,3])
(Comment:de)
C0205161 (UMLS CUI-3)
(Comment:de)
C0027627 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
(Comment:de)
C0153690 (UMLS CUI-3)
C0027627 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
(Comment:de)
C1519246 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
C0349707 (UMLS CUI-2)
(Comment:de)
(Comment:de)
C0005954 (UMLS CUI [1,2])
C0520510 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
C0005953 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,5])
C1521902 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0243095 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C3830456 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
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])
C0432510 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)