ID
28181
Beskrivning
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
Nyckelord
Versioner (5)
- 2017-12-26 2017-12-26 -
- 2017-12-27 2017-12-27 -
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
- 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
- 2021-09-20 2021-09-20 -
Rättsinnehavare
Universität zu Köln
Uppladdad den
27 december 2017
DOI
10.21961/mdm:28181
Licens
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
Medical history
- 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
Beskrivning
Begleiterkrankungen
Beskrivning
Elemente der initialen Therapie (vor jedem Rezidiv)*
Beskrivning
Start date therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
Einschließlich Konsolidierung mit Retinsäure oder Immuntherapie
Datatyp
date
Måttenheter
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C1531784
Beskrivning
Monoclonal Antibody Therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0279694
Beskrivning
High dose Chemotherapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3665472
Beskrivning
MIBG
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0047506
Beskrivning
Radiation therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1522449
Beskrivning
Remission
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Beskrivning
Rezidive/Progressionen
Beskrivning
Angaben zu vorherigen Rezidiven
Beskrivning
Recurrent disease number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0750480
- UMLS CUI [1,2]
- C0277556
Beskrivning
Date of recurrent disease
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0277556
Beskrivning
Systemisch: Nachweis von Fern-Metastasen
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0475437
- UMLS CUI [1,2]
- C0277556
Beskrivning
Malignant neoplasm of bone marrow
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C2703042
Beskrivning
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0686619
- UMLS CUI [1,2]
- C0443203
Beskrivning
Recurrent disease liver
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0023884
Beskrivning
Recurrent disease skin
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0277556
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0277556
Beskrivning
Other recurrent disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beskrivning
Other recurrent disease specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beskrivning
Therapie
Beskrivning
Start date of treatment
Datatyp
date
Måttenheter
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C1531783
Beskrivning
Therapy end date
Datatyp
date
Måttenheter
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C1531783
Beskrivning
Sofern vorhanden:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0277556
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Monoclonal Antibody Therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0279694
Beskrivning
Chemotherapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3665472
Beskrivning
mIBG
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0454107
Beskrivning
Therapeutic radiology procedure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1522449
Beskrivning
Status of disease remission
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0679868
- UMLS CUI [1,2]
- C0231290
Beskrivning
Informationen zum aktuellen Rezidiv
Alias
- UMLS CUI-1
- C0277556
Beskrivning
Datum des Rezidivs/Progression
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0277556
Beskrivning
Systemisch: Nachweis von Fern-Metastasen
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0475437
- UMLS CUI [1,2]
- C0277556
Beskrivning
Malignant neoplasm of bone marrow
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C2703042
Beskrivning
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0686619
- UMLS CUI [1,2]
- C0443203
Beskrivning
Recurrent disease liver
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0023884
Beskrivning
Recurrent disease skin
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0277556
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0277556
Beskrivning
Other recurrent disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beskrivning
Other recurrent disease specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beskrivning
Footer module
Similar models
Medical history
- 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
C2316983 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
(Comment:de)
C0521428 (UMLS CUI-2)
C4086990 (UMLS CUI-3)
(Comment:de)
C0521428 (UMLS CUI-2)
C4086632 (UMLS CUI-3)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C2703042 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C2939420 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0432510 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C1521902 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0205276 (UMLS CUI-2)
(Comment:de)
(Comment:de)
C2703042 (UMLS CUI [1,2])
C0443203 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0205276 (UMLS CUI-2)
(Comment:de)
(Comment:de)
C2703042 (UMLS CUI [1,2])
C0443203 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])