A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117)
I. Determine the progression-free survival of patients with primary or recurrent potentially
resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant
II. Determine the objective response rate of patients treated with this drug. III. Determine
the safety of this drug in these patients.
Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the
absence of disease progression. Patients with disease progression are considered for
immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection
to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib
mesylate once daily for 2 years.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in biological markers of imatinib mesylate, including c-kit and tyrosine
From baseline to 2 years
Radiation Therapy Oncology Group
United States: Food and Drug Administration
|Radiation Therapy Oncology Group||Philadelphia, Pennsylvania 19107|