Pharmacokinetic Study of Doxorubicin in Children With Cancer

NCT01095926 | Completed Phase 2 DMC

• 2 other identifiers: EPOC-MS-0012009-011454-17
• Study Type: interventional
• Target: 101
• Locations: 4 countries
• Sites: 23

Brief Summary

Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .

Conditions

Wilms Tumor; Neuroblastoma; Soft Tissue Sarcoma; Acute Lymphoblastic Leukemia

Keywords

pharmacokinetic; doxorubicin; cancer; troponin; natriuretic peptide; cardiotoxicity; anthracyclines; Ewing; ALL

Outcome Measures

Primary Outcomes (1)

• Assess age-dependency in pharmacokinetics of doxorubicin in paediatric patients with solid tumours and leukaemia

  Measure doxorubicin and doxorubicinol concentration in blood plasma. Collect samples at two different doxorubicin infusions.

  24h

Secondary Outcomes (4)

• Assess interindividual, intraindividual and residual variability of PK parameters in children

  24h

• Assess relationship between PK parameters and patient characteristics

  24h

• Explore in a preliminary fashion genetic polymorphisms that may influence doxorubicin clearance

  5 years

• Evaluate the potential role of natriuretic peptides and troponin as indicators for subclinical cardiotoxicity

  1 month

Study Arms (1)

Doxorubicin

EXPERIMENTAL

Drug: doxorubicin

Interventions

doxorubicin DRUG

blood sampling before, during and after doxorubicin administration

Doxorubicin

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients ≤ 17 years of age
• plan to receive at least two cycles of doxorubicin
• must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients \< 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
• Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
• Life expectancy of at least 3 month
• Karnofsky performance status of ≥ 70%
• Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator

You may not qualify if:

• prior cardiac problems

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (23)

Centre Oscar Lambret

Lille, France

Location

CHU La Timone

Marseille, France

Location

MD Nicolas Andre, National Study Manager France

Marseille, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

Institut curie

Paris, France

Location

Institut Gustanve Roussy

Paris, France

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60690, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Kiel

Kiel, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Klinikum Stuttgart

Stuttgart, Germany

Location

Prof. Maurizio D'Incalci, National Study Manager Italy

Milan, Italy

Location

Università degli Studi di Milano

Monza, Italy

Location

Clinica di Oncoematologia Pediatrica

Padua, Italy

Location

Università Cattolica di Roma

Rome, Italy

Location

Birmingham Childrens Hospital

Birmingham, United Kingdom

Location

St James's University Hospital

Leeds, United Kingdom

Location

Great Ormond Street Hospital for Children

London, United Kingdom

Location

Royal Manchester Childrens Hospital

Manchester, United Kingdom

Location

Prof. Alan Boddy, National Study Manager UK

Newcastle upon Tyne, United Kingdom

Location

Royal Victoria Infirmary, Sir James Spence Institute of Child Health

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Wilms Tumor; Neuroblastoma; Sarcoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms; Cardiotoxicity

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Joachim Boos, MD, Prof.

  University Hospital Muenster

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 30, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2010-03

Locations

FR (7); IT (4); DE (6); GB (6)