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
Keywords
Versions (5)
- 12/26/17 12/26/17 -
- 12/27/17 12/27/17 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
Universität zu Köln
Uploaded on
December 27, 2017
DOI
10.21961/mdm:28181
License
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
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013516
Description
Cardiac ejection fraction
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0232174
Description
Electrocardiography date
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Description
ECG finding
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG abnormal reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0362082
Description
Findings sent to patient?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C1519246
Description
Laboruntersuchungen
Description
White Blood Cell Count
Data type
integer
Measurement units
- Mikroliter
Alias
- UMLS CUI [1]
- C0023508
Description
Absolute neutrophil count
Data type
integer
Measurement units
- yL
Alias
- UMLS CUI [1]
- C0948762
Description
Hemoglobin
Data type
integer
Measurement units
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Description
Blood Platelets
Data type
integer
Measurement units
- yL
Alias
- UMLS CUI [1]
- C0005821
Description
Glucose measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0337438
Description
Tumormarker
Description
NSE
Data type
integer
Measurement units
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Description
NSE result
Data type
integer
Alias
- UMLS CUI [1]
- C0202144
Description
LDH
Data type
integer
Measurement units
- U/l
Alias
- UMLS CUI [1]
- C0202113
Description
LDH result
Data type
integer
Alias
- UMLS CUI [1]
- C0202113
Description
Urine VMA level result
Data type
integer
Measurement units
- mg/g Crea
Alias
- UMLS CUI [1]
- C1261438
Description
Unit vma
Data type
integer
Alias
- UMLS CUI [1,1]
- C1261438
- UMLS CUI [1,2]
- C1519795
Description
age dependent vma factor
Data type
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Description
vma result
Data type
integer
Alias
- UMLS CUI [1]
- C1261438
Description
homovanillic acid
Data type
integer
Measurement units
- mg/g Crea
Alias
- UMLS CUI [1]
- C0202071
Description
homovanillic acid unit
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C0439148
Description
age dependent factor
Data type
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Description
Homovanillic acid measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202071
Description
Surrogatmarker
Description
Immunophenotyping
Data type
boolean
Alias
- UMLS CUI [1]
- C0079611
Description
Collection of blood specimen for laboratory procedure date in time
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Shipping
Data type
date
Measurement units
- 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
Data type
boolean
Alias
- UMLS CUI [1]
- C0024485
- UMLS CUI [2]
- C0040405
Description
mIBG
Data type
boolean
Alias
- UMLS CUI [1]
- C0047506
Description
Bone Marrow Examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0005957
Description
Other examination?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
Description
Specify other examination
Data type
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
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0024485
Description
Evaluation method
Data type
integer
Alias
- UMLS CUI [1]
- C2911685
Description
Anatomic site
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
Primary tumor
Data type
integer
Alias
- UMLS CUI [1]
- C0677930
Description
Status of distant metastasis
Data type
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.
Data type
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3830456
- UMLS CUI [1,2]
- C2939420
- UMLS CUI [1,3]
- C0024485
Description
Secondary malignant neoplasm of liver
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0024485
Description
Secondary malignant neoplasm of skin
Data type
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0686377
Description
Neoplasm Metastasis; Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
Description
Specify other neoplasm metastasis
Data type
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
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0011008
Description
MIBG Finding primary tumor
Data type
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0677930
Description
mIBG findings metastasis
Data type
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C4255448
Description
MIBG scintiscan findings sent
Data type
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
Data type
integer
Alias
- UMLS CUI [1]
- C0005957
Description
Bone marrow biopsy date
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Description
Bone marrow sent?
Data type
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
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Description
Specimen sent?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519246
Description
Examination method specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Description
Finding primary tumor
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0677930
Description
Findings bone metastases
Data type
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Description
Finding distant lymph node
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C3830456
Description
Liver finding
Data type
integer
Alias
- UMLS CUI [1]
- C0426686
Description
Skin finding
Data type
integer
Alias
- UMLS CUI [1]
- C0455205
Description
Finding CNS
Data type
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Description
Finding other metastases
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1335151
Description
Other Metastasis specify
Data type
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
Data type
text
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0432510
Description
Date
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature
Data type
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)