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