Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor

Terminated

1

Start Date 07/01/2007

Age of Trial (yrs) 17.5

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

VICC-GI-0621, P30CA068485, VU-VICC-GI-0621

Vanderbilt-Ingram Cancer Center NCI

Oral

OBJECTIVES:

To determine the maximum tolerated dose of imatinib mesylate in combination with sunitinib malate in patients with gastrointestinal stromal tumors.
To determine the toxicity of this regimen in these patients.
To determine the antitumor activity in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.

Patients receive oral sunitinib malate once daily on days 1-14 in course 1 and on days 1-42 in all subsequent courses. Beginning in course 2, patients also receive oral imatinib mesylate once or twice daily on days 1-42. Courses repeat every 6 weeks in the absence of unacceptable toxicity.

Blood samples are collected on day 15 and day 43 for pharmacokinetics.

After completion of study treatment, patients are followed every 6 months.