Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00328029
First received: May 18, 2006
Last updated: February 24, 2009
Last verified: February 2009
  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
Procedure: pharmacokinetics, done during the treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population

Resource links provided by NLM:


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 [ Time Frame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison to respiratory side effect frequency with TBI conditioning regimen [ Time Frame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months). ] [ Designated as safety issue: Yes ]
  • Busulfan pharmacokinetics [ Time Frame: after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h ; 3 h after 2nd Busulfan taken ; 3 hours after 3rd Busulfan taken ; 3 h after 4st Busulfan taken ;3 h after 5st Busulfan taken ;3 h after 6st Busulfan taken ] [ Designated as safety issue: No ]
  • Establish a potential link between respiratory side effects and busulfan pharmacokinetics [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: July 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: busulfan
    5mg/kg/day (oral route : 4 doses/day for 4 days)
    Procedure: respiratory function tests
    respiratory function tests before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
    Other Name: 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

    12 blood collections :

    • after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h.
    • 3 hours after 2nd taken of Busulfan
    • 3 hours after 3rd taken of Busulfan
    • 3 hours after 4th taken of Busulfan
    • 3 hours after 5th taken of Busulfan
    • 3 hours after 6th taken of Busulfan.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00328029     History of Changes
Other Study ID Numbers: 2999
Study First Received: May 18, 2006
Last Updated: February 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 24, 2014