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

NCT00328029 | Unknown Phase 2

• 1 other identifier: 2999
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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

Keywords

Busulfan; pharmacokinetic; respiratory function assessment; Busulfan pharmacokinetic and respiratory function tests

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (3)

• 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).

• 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

• Establish a potential link between respiratory side effects and busulfan pharmacokinetics

Interventions

busulfan DRUG

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

respiratory function tests PROCEDURE

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

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

pharmacokinetics, done during the treatment PROCEDURE

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 Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (2)

Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil

Strasbourg, 67091, France

RECRUITING

Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Interventions

Busulfan; Respiratory Physiological Phenomena; Transplantation, Autologous; Pharmacokinetics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Circulatory and Respiratory Physiological Phenomena; Transplantation; Surgical Procedures, Operative; Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Patrick Lutz, MD

  Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

  STUDY DIRECTOR

Central Study Contacts

Patrick Lutz, MD

CONTACT

3.33.88.12.80.90; patrick.lutz@chru-strasbourg.fr

Natacha Entz-Werle, MD

CONTACT

3.33.88.12.80.99; natacha.entz-werle@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 25, 2009

Record last verified: 2009-02

Locations

FR (2)