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

Signs and Symptoms, Respiratory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00328029
• Other study ID #: 2999
• Status: Recruiting
• Phase: Phase 2
• First received: May 18, 2006
• Last updated: February 24, 2009
• Start date: July 2006
• Est. completion date: June 2012

Study information

• Verified date: February 2009
• Source: University Hospital, Strasbourg, France
• Contact: Patrick Lutz, MD
• Phone: 3.33.88.12.80.90
• Email: patrick.lutz[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Signs and Symptoms
• Signs and Symptoms, Respiratory

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil	Strasbourg
France	Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan		before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).	Yes
Secondary	Comparison to respiratory side effect frequency with TBI conditioning regimen		before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).	Yes
Secondary	Busulfan pharmacokinetics		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	No
Secondary	Establish a potential link between respiratory side effects and busulfan pharmacokinetics			Yes