Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST (MDACC)

Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST (MDACC)

GIST

Completed

2

Start Date 07/01/2003

Age of Trial (yrs) 21.7

Adjuvant Neoadjuvant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

ID03-0023

MD Anderson, Novartis

Jon Trent, MD, PhD

713-792-3626

Randomized

Oral

Primary objectives

1. To determine whether induction of apoptosis or inhibition of angiogenesis are involved in the antitumor activity of Gleevec in patients with GIST as assessed by PET scanning.
2. To determine whether dynamic CT, PET scan, molecular and histopathologic responses in GIST tumors from patients treated with Gleevec predict DFS time.

Secondary objectives

1. To determine the disease free survival of patients with resectable or partially resectable GI stromal tumors treated with Gleevec preoperatively and continued for 2 years after resection of disease.
2. To assess the safety and tolerability of Gleevec given to patients with GI stromal tumors 3, 5, or 7 days preoperatively and continued postoperatively.