ID
28181
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
27 december 2017
DOI
10.21961/mdm:28181
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
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
Beschrijving
Begleiterkrankungen
Beschrijving
Elemente der initialen Therapie (vor jedem Rezidiv)*
Beschrijving
Start date therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
Einschließlich Konsolidierung mit Retinsäure oder Immuntherapie
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C1531784
Beschrijving
Monoclonal Antibody Therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0279694
Beschrijving
High dose Chemotherapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C3665472
Beschrijving
MIBG
Datatype
boolean
Alias
- UMLS CUI [1]
- C0047506
Beschrijving
Radiation therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C1522449
Beschrijving
Remission
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
Beschrijving
Rezidive/Progressionen
Beschrijving
Angaben zu vorherigen Rezidiven
Beschrijving
Recurrent disease number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0750480
- UMLS CUI [1,2]
- C0277556
Beschrijving
Date of recurrent disease
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0277556
Beschrijving
Systemisch: Nachweis von Fern-Metastasen
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0475437
- UMLS CUI [1,2]
- C0277556
Beschrijving
Malignant neoplasm of bone marrow
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C2703042
Beschrijving
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0686619
- UMLS CUI [1,2]
- C0443203
Beschrijving
Recurrent disease liver
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0023884
Beschrijving
Recurrent disease skin
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0277556
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 [1,1]
- C3714787
- UMLS CUI [1,2]
- C0277556
Beschrijving
Other recurrent disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beschrijving
Other recurrent disease specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beschrijving
Therapie
Beschrijving
Start date of treatment
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C1531783
Beschrijving
Therapy end date
Datatype
date
Maateenheden
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C1531783
Beschrijving
Sofern vorhanden:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0277556
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Monoclonal Antibody Therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0279694
Beschrijving
Chemotherapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C3665472
Beschrijving
mIBG
Datatype
boolean
Alias
- UMLS CUI [1]
- C0454107
Beschrijving
Therapeutic radiology procedure
Datatype
boolean
Alias
- UMLS CUI [1]
- C1522449
Beschrijving
Status of disease remission
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0679868
- UMLS CUI [1,2]
- C0231290
Beschrijving
Informationen zum aktuellen Rezidiv
Alias
- UMLS CUI-1
- C0277556
Beschrijving
Datum des Rezidivs/Progression
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0277556
Beschrijving
Systemisch: Nachweis von Fern-Metastasen
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0475437
- UMLS CUI [1,2]
- C0277556
Beschrijving
Malignant neoplasm of bone marrow
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C2703042
Beschrijving
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0686619
- UMLS CUI [1,2]
- C0443203
Beschrijving
Recurrent disease liver
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0023884
Beschrijving
Recurrent disease skin
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0277556
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 [1,1]
- C3714787
- UMLS CUI [1,2]
- C0277556
Beschrijving
Other recurrent disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beschrijving
Other recurrent disease specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0277556
Beschrijving
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])