Glivec Phase II Pediatric Study

Phase 2

Terminated

• Conditions: Cancer

• Registration Number: NCT00180830
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-07
• Last Update Posted: 2006-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients from 6 months to 21 years of age.
• Malignant disease documented by conventional criteria to be refractory to standard, approved therapy, or for which no conventional therapies of definitive benefit exist.
• Immunohistochemistry documentation of positivity of either Kit (CD117) or PDGF-R in tumor tissue relevant. Each positive tumor will be centrally reviewed before inclusion of the patient in the trial.
• Measurable or evaluable disease.
• WHO Performance status 0,1, or 2 or Lansky Play Scale >= 50%.
• Adequate organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic disease involvement is present), creatinine < 1.5 x ULN, ANC > 1x 109/L, platelets > 75 x 109/L.
• Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
• Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
• Life expectancy of more than 6 weeks.
• Written, voluntary, informed consent, including consent for retrieval and investigational use of tissue samples for evaluation signed by parents or young adult patients.
• National and, when needed, local ethical approval.

Exclusion Criteria

• Patient with hematological disease positive for the chimeric BCR-ABL fusion protein or for c-kit.
• Patient has received any other investigational agents within 28 days of first day of study drug dosing.
• Female patients who are pregnant or breast-feeding.
• Patient has another severe and/or life-threatening medical diseasePatient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by the study coordinator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
- Tumour Response

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival, overall Survival, safety and tolerability, pharmacokinetic profile and pharmacodynamics of Glivec, pharmacogenetics

Trial Locations

Locations (3)

Institut Gustave-Roussy; 🇫🇷 Villejuif, France

Emma Kinderziekenhuis AMC; 🇳🇱 Amsterdam, Netherlands

Birmingham Children's Hospital; 🇬🇧 Birmingham, United Kingdom