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

February 24, 2009 updated by: University Hospital, Strasbourg, France

Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population

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.

Study Overview

Status

Unknown

Conditions

Signs and Symptoms, Respiratory

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).

Secondary Outcome Measures

Outcome Measure	Time Frame
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).	before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
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	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
Establish a potential link between respiratory side effects and busulfan pharmacokinetics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

Study Director: Patrick Lutz, MD, Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria