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

NCT ID: NCT00328029

Last Updated: 2009-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-06-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

busulfan

5mg/kg/day (oral route : 4 doses/day for 4 days)

Intervention Type: DRUG

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Principal Investigators

Patrick Lutz, MD

Role: STUDY_DIRECTOR

Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

Locations

Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil

Strasbourg, , France

Site Status: RECRUITING

Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick Lutz, MD

Role: CONTACT

patrick.lutz@chru-strasbourg.fr

3.33.88.12.80.90

Natacha Entz-Werle, MD

Role: CONTACT

natacha.entz-werle@chru-strasbourg.fr

3.33.88.12.80.99

Facility Contacts

Charloux Anne, MD

Role: primary

anne.charloux@chru-strasbourg.fr

3.33.88.11.61.22

Oswald Monique, MD

Role: backup

monique.oswald@chru-strasbourg.fr

3.33.88.11.68.61

Patrick Lutz, MD

Role: primary

patrick.lutz@chru-strasbourg.fr

3.33.88.12.80.90

Natacha Entz-Werle, MD

Role: backup

natacha.entz-werle@chru-strasbourg.fr

3.33.88.12.80.99

Other Identifiers

2999

Identifier Type: -

Identifier Source: org_study_id