Glivec Phase II Pediatric Study

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Imatinib Mesylate

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.