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
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
September 20, 2021
DOI
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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
Therapeutic response
- 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
Allgemeine Untersuchungen
Description
Untersuchung sollte innerhalb von 14 Tagen nach Ende des 6. Zyklus bzw. EOT durchgeführt werden.
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Weight
Data type
integer
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body surface
Data type
text
Alias
- UMLS CUI [1]
- C0005902
Description
Systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Karnofsky
Data type
integer
Alias
- UMLS CUI [1]
- C0206065
Description
Kardiologische Untersuchungen
Alias
- UMLS CUI-1
- C0007189
- UMLS CUI-2
- C0031809
Description
Date in time 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 in time
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Description
EKG finding
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG finding
Data type
text
Alias
- UMLS CUI [1]
- C0438154
Description
Laboruntersuchungen
Description
White Blood Cell Count procedure
Data type
integer
Measurement units
- μL
Alias
- UMLS CUI [1]
- C0023508
Description
Neutrophil count
Data type
integer
Measurement units
- μL
Alias
- UMLS CUI [1]
- C0200633
Description
Hemoglobin measurement
Data type
integer
Measurement units
- g/dl
Alias
- UMLS CUI [1]
- C0518015
Description
Blood Platelets
Data type
integer
Measurement units
- μL
Alias
- UMLS CUI [1]
- C0005821
Description
Glucose measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0004076
Description
Tumormarker
Alias
- UMLS CUI-1
- C0041365
Description
Neuron specific enolase measurement
Data type
integer
Measurement units
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Description
Neuron specific enolase measurement result
Data type
text
Alias
- UMLS CUI [1]
- C0202144
Description
Lactate dehydrogenase measurement
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
Urine VMA level result; Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C1261438
- UMLS CUI [1,2]
- C1519795
Description
Age-dependent penetrance; vanilmandelic acid; Factor
Data type
text
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Description
Urine VMA level result
Data type
integer
Alias
- UMLS CUI [1]
- C1261438
Description
Homovanillic acid measurement
Data type
integer
Measurement units
- mg/g Crea
Alias
- UMLS CUI [1]
- C0202071
Description
Homovanillic acid measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C0439148
Description
Age-dependent homovanillic acid measurement
Data type
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Description
HVA result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C1274040
Description
Staging Untersuchungen
Description
Magnetic Resonance Imaging; X-Ray Computed Tomography
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024485
- UMLS CUI [1,2]
- C0040405
Description
MIBG
Data type
boolean
Alias
- UMLS CUI [1]
- C2229074
Description
Bone Marrow Examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0005957
Description
Other specified examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0260879
Description
Lokale MRT/CT Beurteilung
Description
MRT Untersuchungen werden bevorzugt
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2985720
Description
Evaluation Method
Data type
integer
Alias
- UMLS CUI [1]
- C2911685
Description
Anatomic Site
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
Anatomic Site Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0205394
Description
primary tumor
Data type
integer
Alias
- UMLS CUI [1]
- C0677930
Description
Malignant Neoplasms Measurable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1513040
Description
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
Description
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Data type
boolean
Alias
- UMLS CUI [1]
- C0686619
Description
Secondary malignant neoplasm of liver
Data type
boolean
Alias
- UMLS CUI [1]
- C0494165
Description
Secondary malignant neoplasm of skin
Data type
boolean
Alias
- UMLS CUI [1]
- C0153687
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
Neoplasm Metastasis Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Description
Diagnostic Imaging
Data type
boolean
Alias
- UMLS CUI [1]
- C0011923
Description
Lokale mIBG-Beurteilung
Description
MIBG scintiscan; Date in time
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0011008
Description
MIBG scintiscan finding primary tumor
Data type
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0677930
Description
MIBG scintiscan finding metastasis
Data type
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C4255448
Description
MIBG scintiscan send
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C1519246
- UMLS CUI [1,3]
- C0220825
Description
Knochenmarkuntersuchungen
Description
Method
Data type
text
Alias
- UMLS CUI [1]
- C0005957
Description
Date in time; Bone marrow biopsy
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
Description
Examination method
Data type
date
Measurement units
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Description
Findings sent?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519246
Description
Examination by method; To specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Description
primary tumor
Data type
integer
Alias
- UMLS CUI [1]
- C1305853
Description
Secondary malignant neoplasm of bone; Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Description
Finding distan lymph nodes
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
Central Nervous System; Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Description
Neoplasm Metastasis; Other; Other Finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1335151
Description
To specify; Neoplasm Metastasis; Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Description
Gesamtbeurteilung
Description
Date of diagnosis; Tumor finding
Data type
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C1274082
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
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
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
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
Description
Footer module
Similar models
Therapeutic response
- 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
C0027646 (UMLS CUI [1,2])
C0027646 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0013516 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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C1519795 (UMLS CUI [1,2])
C0042317 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
C0439148 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,2])
C0202071 (UMLS CUI [1,3])
C0205307 (UMLS CUI-2)
(Comment:de)
C1521733 (UMLS CUI-2)
(Comment:de)
C0040405 (UMLS CUI [1,2])
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C0205394 (UMLS CUI [1,2])
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C1513040 (UMLS CUI [1,2])
(Comment:de)
C1275402 (UMLS CUI-2)
(Comment:de)
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])
C0243095 (UMLS CUI [1,2])
C4255448 (UMLS CUI [1,3])
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])
C0243095 (UMLS CUI [1,2])
C3830456 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1335151 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1274082 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
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C0449438 (UMLS CUI [1,2])
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C0449438 (UMLS CUI [1,2])
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(Comment:de)
(Comment:de)
C0449438 (UMLS CUI [1,2])
(Comment:de)
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