Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. To determine the activity of Gleevec\^trademark (TM) (imatinib mesylate) as measured by progression-free survival at six months. II. To determine the frequency and severity of adverse effects of Gleevec\^TM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Events version 3.0 (CTCAE v3.0). SECONDARY OBJECTIVES: I. To determine the distribution of progression-free survival and overall survival. II. To estimate the objective response rate (partial and complete response as defined under the Response Evaluation Criteria In Solid Tumors \[RECIST\] criteria). III. To determine the effects of prognostic factors such as initial performance status and histological grade. TERTIARY OBJECTIVES: I. To determine the levels of expression of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (c-KIT), platelet-derived growth factor receptor (PDGFR), v-akt murine thymoma viral oncogene homolog 2 (AKT2), and phosphorylated (p)-AKT2 in archived, formalin-fixed, paraffin-embedded primary tumors collected prior to the initiation of first-line chemotherapy OUTLINE: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
