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

NCT00328029 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-02-25

No results posted yet for this study

Summary

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.

Conditions

  • Signs and Symptoms, Respiratory

Interventions

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).

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.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Patrick Lutz, MD · Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00328029 on ClinicalTrials.gov