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