ID
42004
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
15. März 2021
DOI
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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
Registration
- 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
Einschlusskriterien
Beschreibung
Rezidiv oder Progression eines Hochrisikoneuroblastoms (nach INSS und GPOH-Kriterien) unabhängig von der Anzahl vorausgehender Rezidive/Progressionen?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027819
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Measurable or evaluable disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1513041
Beschreibung
Minimal interval between start of trial medication and preceding anti-cancer treatment
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272706
Beschreibung
Life expectancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023671
Beschreibung
Good to moderate general condition
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142435
Beschreibung
No serious infection
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205404
Beschreibung
Spontaneous recovering blood counts
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005771
Beschreibung
Follow-up period
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1522577
Beschreibung
Written informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Ausschlusskriterien
Beschreibung
Minimal residual disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1511791
Beschreibung
Patients unable to swallow trial medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3839225
Beschreibung
Concomitant anti-cancer treatment
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Antihypertensive drugs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003364
Beschreibung
Hypersensitivity to medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
Beschreibung
Severe medical or psychosocial conditions preventing trial participate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Peripheral neuropathy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0031117
Beschreibung
Cardiac arrhythmias
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003811
Beschreibung
Bronchial asthma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004096
Beschreibung
Diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschreibung
Low blood pressure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0020649
Beschreibung
History of gastrointestinal ulcer or perforation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030920
- UMLS CUI [2]
- C0151664
Beschreibung
Known active hepatitis B virus (HBV), hepatitis C (HBC) virus or human immunodeficiency virus (HIV) infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0220847
Beschreibung
Concomitant participation in other clinical trials
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Pregnancy, lactation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beschreibung
Sexually active patients not willing to use highly effective contraception
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
Studieneinschluss
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C2348563
Beschreibung
Informed Consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Ähnliche Modelle
Registration
- 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
(Comment:de)
(Comment:de)
C0205404 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0151664 (UMLS CUI [2])
C0019163 (UMLS CUI [2])
C0220847 (UMLS CUI [3])
C0006147 (UMLS CUI [2])