Glivec Phase II Pediatric Study

This study has been terminated.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00180830
First received: September 9, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Cancer
Drug: Glivec
Drug: Gleevec
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • - Tumour Response

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

Estimated Enrollment: 36
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180830

Locations
France
Institut Gustave-Roussy
Villejuif, France, 94805
Netherlands
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
Investigators
Study Chair: Gilles Vassal, MD,PhD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Bruce Morland Birmingham Children’s Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180830     History of Changes
Other Study ID Numbers: EGPS-01, CSET-2002/940, CSTI 571BFR10
Study First Received: September 9, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014