Drug: |
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Trial Name: |
Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST (MDACC) |
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NCT#: |
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Conditions: |
GIST |
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Status: |
Completed |
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Phase: |
2 |
Start Date 07/01/2003 |
Age of Trial (yrs) 21.8 |
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Treatment Phase: |
Adjuvant
Neoadjuvant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
ID03-0023 |
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Sponsor: |
MD Anderson,
Novartis |
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Patient Contact: |
Jon Trent, MD, PhD |
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Contact email: |
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Contact Phone: |
713-792-3626 |
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Randomized: |
Randomized |
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IV or Oral: |
Oral |
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Trial Notes: |
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. |
Trial Links |
Trial Results |
Name |
Address |
City |
State |
Zip |
Country |
1505 Holcombe Blvd. |
Houston |
TX |
77030 |
USA |