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

September 9, 2005
September 16, 2005
September 11, 2006
December 2003
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- Tumour Response
Same as current
Complete list of historical versions of study NCT00180830 on Archive Site
Progression-free Survival, overall Survival, safety and tolerability, pharmacokinetic profile and pharmacodynamics of Glivec, pharmacogenetics
  • - Progression-free Survival
  • - Overall Survival
  • - Safety and tolerability
  • - Phrmacokinetic profile and pharmacodynamics of Glivec
  • - Pharmacogenetics
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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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Glivec
  • Drug: Gleevec
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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.
Sexes Eligible for Study: All
6 Months to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Netherlands,   United Kingdom
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Gustave Roussy, Cancer Campus, Grand Paris
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Study Chair: Gilles Vassal, MD,PhD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Bruce Morland Birmingham Children’s Hospital
Gustave Roussy, Cancer Campus, Grand Paris
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP