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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


Phase 2
6 Months
21 Years
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

- Tumour Response

Principal Investigator

Gilles Vassal, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EGPS-01

NCT ID:

NCT00180830

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Cancer

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