ID
28181
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
27 décembre 2017
DOI
10.21961/mdm:28181
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
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
Description
Kardiologische Untersuchungen
Alias
- UMLS CUI-1
- C0007189
- UMLS CUI-2
- C0031809
Description
Date of Echocardiography
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013516
Description
Cardiac ejection fraction
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0232174
Description
Electrocardiography date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Description
ECG finding
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG abnormal reason
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0362082
Description
Findings sent to patient?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C1519246
Description
Laboruntersuchungen
Description
White Blood Cell Count
Type de données
integer
Unités de mesure
- Mikroliter
Alias
- UMLS CUI [1]
- C0023508
Description
Absolute neutrophil count
Type de données
integer
Unités de mesure
- yL
Alias
- UMLS CUI [1]
- C0948762
Description
Hemoglobin
Type de données
integer
Unités de mesure
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Description
Blood Platelets
Type de données
integer
Unités de mesure
- yL
Alias
- UMLS CUI [1]
- C0005821
Description
Glucose measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C0337438
Description
Tumormarker
Description
NSE
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]
- C0202144
Description
LDH
Type de données
integer
Unités de mesure
- U/l
Alias
- UMLS CUI [1]
- C0202113
Description
LDH result
Type de données
integer
Alias
- UMLS CUI [1]
- C0202113
Description
Urine VMA level result
Type de données
integer
Unités de mesure
- mg/g Crea
Alias
- UMLS CUI [1]
- C1261438
Description
Unit vma
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1261438
- UMLS CUI [1,2]
- C1519795
Description
age dependent vma factor
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Description
vma result
Type de données
integer
Alias
- UMLS CUI [1]
- C1261438
Description
homovanillic acid
Type de données
integer
Unités de mesure
- mg/g Crea
Alias
- UMLS CUI [1]
- C0202071
Description
homovanillic acid unit
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C0439148
Description
age dependent factor
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Description
Homovanillic acid measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0202071
Description
Surrogatmarker
Description
Immunophenotyping
Type de données
boolean
Alias
- UMLS CUI [1]
- C0079611
Description
Collection of blood specimen for laboratory procedure date in time
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Shipping
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C1524049
- UMLS CUI [1,3]
- C0011008
Description
Lebensqualität
Description
Bildgebung
Alias
- UMLS CUI-1
- C0011923
Description
MRT / CT
Type de données
boolean
Alias
- UMLS CUI [1]
- C0024485
- UMLS CUI [2]
- C0040405
Description
mIBG
Type de données
boolean
Alias
- UMLS CUI [1]
- C0047506
Description
Bone Marrow Examination
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005957
Description
Other examination?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
Description
Specify other examination
Type de données
text
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Description
Lokale MRT/CT Beurteilung
Description
MRT Untersuchungen werden bevorzugt
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0024485
Description
Evaluation method
Type de données
integer
Alias
- UMLS CUI [1]
- C2911685
Description
Anatomic site
Type de données
integer
Alias
- UMLS CUI [1]
- C1515974
Description
Primary tumor
Type de données
integer
Alias
- UMLS CUI [1]
- C0677930
Description
Status of distant metastasis
Type de données
integer
Alias
- UMLS CUI [1]
- C1302548
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0153690
- UMLS CUI [2]
- C0346979
Description
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3830456
- UMLS CUI [1,2]
- C2939420
- UMLS CUI [1,3]
- C0024485
Description
Secondary malignant neoplasm of liver
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0024485
Description
Secondary malignant neoplasm of skin
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0153687
- UMLS CUI [1,2]
- C0024485
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0686377
Description
Neoplasm Metastasis; Other
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
Description
Specify other neoplasm metastasis
Type de données
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Description
Lokale MRT/CT Beurteilung
Description
Lokale mIBG-Beurteilung
Alias
- UMLS CUI-1
- C2229074
Description
MIBG scintiscan date
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0011008
Description
MIBG Finding primary tumor
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0677930
Description
mIBG findings metastasis
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C4255448
Description
MIBG scintiscan findings sent
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C1519246
- UMLS CUI [1,3]
- C0220825
Description
Knochenmarkuntersuchungen
Alias
- UMLS CUI-1
- C0005957
Description
Method Bone Marrow Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0005957
Description
Bone marrow biopsy date
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Description
Bone marrow sent?
Type de données
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
Description
Sonstige Untersuchungen
Alias
- UMLS CUI-1
- C0260879
Description
Examination date
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Description
Specimen sent?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519246
Description
Examination method specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Description
Finding primary tumor
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0677930
Description
Findings bone metastases
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
Finding CNS
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Description
Finding other metastases
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1335151
Description
Other Metastasis specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Description
Gesamtbeurteilung
Description
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0432510
Description
Date
Type de données
date
Unités de mesure
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature
Type de données
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)