ID
42136
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
Mots-clés
Versions (5)
- 26/12/2017 26/12/2017 -
- 27/12/2017 27/12/2017 -
- 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
- 20/09/2021 20/09/2021 -
Détendeur de droits
Universität zu Köln
Téléchargé le
13 avril 2021
DOI
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Licence
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
Description
Einschlusskriterien
Description
Rezidiv oder Progression eines Hochrisikoneuroblastoms (nach INSS und GPOH-Kriterien) unabhängig von der Anzahl vorausgehender Rezidive/Progressionen?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027819
Description
Age
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Measurable or evaluable disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C1513041
Description
Minimal interval between start of trial medication and preceding anti-cancer treatment
Type de données
boolean
Alias
- UMLS CUI [1]
- C1272706
Description
Life expectancy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023671
Description
Good to moderate general condition
Type de données
boolean
Alias
- UMLS CUI [1]
- C1142435
Description
No serious infection
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205404
Description
Spontaneous recovering blood counts
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005771
Description
Follow-up period
Type de données
boolean
Alias
- UMLS CUI [1]
- C1522577
Description
Written informed consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Ausschlusskriterien
Description
Minimal residual disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C1511791
Description
Patients unable to swallow trial medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C3839225
Description
Concomitant anti-cancer treatment
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Antihypertensive drugs
Type de données
boolean
Alias
- UMLS CUI [1]
- C0003364
Description
Hypersensitivity to medication
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
Description
Severe medical or psychosocial conditions preventing trial participate
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Peripheral neuropathy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0031117
Description
Cardiac arrhythmias
Type de données
boolean
Alias
- UMLS CUI [1]
- C0003811
Description
Bronchial asthma
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004096
Description
Diabetes mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Low blood pressure
Type de données
boolean
Alias
- UMLS CUI [1]
- C0020649
Description
History of gastrointestinal ulcer or perforation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030920
- UMLS CUI [2]
- C0151664
Description
Known active hepatitis B virus (HBV), hepatitis C (HBC) virus or human immunodeficiency virus (HIV) infection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0220847
Description
Concomitant participation in other clinical trials
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Pregnancy, lactation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Description
Sexually active patients not willing to use highly effective contraception
Type de données
boolean
Alias
- UMLS CUI [1]
- C0700589
Description
Studieneinschluss
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C2348563
Description
Informed Consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
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])