Glivec Phase II Pediatric Study

Open Label, Pilot Phase II Study of Glivec in Children and Adolescents With Life Threatening Diseases Known to Be Associated With One or More Glivec-Sensitive Tyrosine Kinases

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Drug: Gleevec; Drug: Glivec

• Study Type: Interventional
• Enrollment: 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94805
    • Institut Gustave-Roussy
• Netherlands
  • Amsterdam, Netherlands, 1100 DE
    • Emma Kinderziekenhuis AMC
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Tumour Response

Secondary Outcome Measures

Outcome Measure
Progression-free Survival, overall Survival, safety and tolerability, pharmacokinetic profile and pharmacodynamics of Glivec, pharmacogenetics

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Study Chair: Gilles Vassal, MD,PhD, Gustave Roussy, Cancer Campus, Grand Paris; Study Chair: Bruce Morland, Birmingham Children's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2003

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): September 11, 2006
• Last Update Submitted That Met QC Criteria: September 7, 2006
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: EGPS-01; CSET-2002/940; CSTI 571BFR10