Glivec Phase II Pediatric Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180830
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : September 11, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Glivec Drug: Gleevec Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. - Tumour Response

Secondary Outcome Measures :
  1. Progression-free Survival, overall Survival, safety and tolerability, pharmacokinetic profile and pharmacodynamics of Glivec, pharmacogenetics

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180830

Institut Gustave-Roussy
Villejuif, France, 94805
Emma Kinderziekenhuis AMC
Amsterdam, Netherlands, 1100 DE
United Kingdom
Birmingham Children’s Hospital
Birmingham, United Kingdom, B4 6NH
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Gilles Vassal, MD,PhD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Bruce Morland Birmingham Children’s Hospital Identifier: NCT00180830     History of Changes
Other Study ID Numbers: EGPS-01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action