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Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, February 2008
Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00328029
  Purpose

Recently, several conditioning regimens did not include total body irradiation (TBI) anymore, especially in the case of young children due to cognitive sequelae and late effects on growth and height. Thus, such effective chemotherapy conditioning regimens were developed to avoid these complications. Busulfan is one of the major drugs used in these treatments, but, is also administered in high dose chemotherapy followed by autograft. In both situations, long term pulmonary side effects were diagnosed in a few cases. Even if the occurrence is not very frequent, the clinical management is a real challenge regarding the reduced quality of life and life expectancy of these patients. Up to now, no correlation was done between respiratory sequelae and busulfan pharmacokinetics. Hence, in the investigators' pediatric onco-hematological unit, a prospective study will begin and last three years to assess the respiratory side effects due to busulfan and their potential links with individual drug pharmacokinetic measures. These results will be compared to patients treated with TBI during the same period of time.


Condition Intervention Phase
Signs and Symptoms, Respiratory
Drug: busulfan
Procedure: respiratory function tests, before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
Procedure: pharmacokinetics, done during the treatment
Phase II

Drug Information available for: Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan

Secondary Outcome Measures:
  • Comparison to respiratory side effect frequency with TBI conditioning regimen
  • Busulfan pharmacokinetics
  • Establish a potential link between respiratory side effects and busulfan pharmacokinetics

Estimated Enrollment: 35
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients above 3 years old treated by busulfan or TBI in their conditioning regimens before allograft or busulfan in high dose chemotherapeutic regimens followed by autograft will be included after parents informed assent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328029

Contacts
Contact: Patrick Lutz, MD 3.33.88.12.80.90 patrick.lutz@chru-strasbourg.fr
Contact: Natacha Entz-Werle, MD 3.33.88.12.80.99 natacha.entz-werle@chru-strasbourg.fr

Locations
France
Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Patrick Lutz, MD     3.33.88.12.80.90     patrick.lutz@chru-strasbourg.fr    
Contact: Natacha Entz-Werle, MD     3.33.88.12.80.99     natacha.entz-werle@chru-strasbourg.fr    
Principal Investigator: Patrick Lutz, MD            
Sub-Investigator: Natacha Entz-Werle, MD            
Sub-Investigator: Nadine COJEAN, MD            
Sub-Investigator: Sophie BAYART, MD            
Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Charloux Anne, MD     3.33.88.11.61.22     anne.charloux@chru-strasbourg.fr    
Contact: Oswald Monique, MD     3.33.88.11.68.61     monique.oswald@chru-strasbourg.fr    
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Patrick Lutz, MD Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
  More Information

Study ID Numbers: 2999
Study First Received: May 18, 2006
Last Updated: February 29, 2008
ClinicalTrials.gov Identifier: NCT00328029  
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Busulfan
pharmacokinetic
respiratory function assessment
Busulfan pharmacokinetic and respiratory function tests

Study placed in the following topic categories:
Signs and Symptoms
Busulfan
Signs and Symptoms, Respiratory

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009