Glivec Phase II Pediatric Study

NCT00180830 | Terminated Phase 2

• 3 other identifiers: EGPS-01CSET-2002/940CSTI 571BFR10
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 3

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• - Tumour Response

Secondary Outcomes (1)

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

Interventions

Glivec DRUG

Gleevec DRUG

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (3)

Institut Gustave-Roussy

Villejuif, 94805, France

Location

Emma Kinderziekenhuis AMC

Amsterdam, 1100 DE, Netherlands

Location

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Gilles Vassal, MD,PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• Bruce Morland

  Birmingham Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2003
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

GB (1); FR (1); NL (1)