Recurrent Neuroendocrine Carcinoma of the Skin Clinical Trial
Official title:
A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
This phase II trial is studying how well imatinib mesylate works in treating patients with metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PRIMARY OBJECTIVES:
I. To assess the feasibility of a Southwest Oncology Group Phase II trial or oral
STI-571/imatinib (Gleevec) administered to patients with metastatic or unresectable Merkel
cell carcinoma.
II. To evaluate the objective response probability (confirmed and unconfirmed complete and
partial responses) of oral STI-571/imatinib (Gleevec) administered to patients with
metastatic or unresectable Merkel cell carcinoma.
III. To assess qualitative and quantitative toxicities of oral STI-581/imatinib (Gleevec)
administered to patients with metastatic or unresectable Merkel cell carcinoma.
IV. To analyze tumor samples for activating mutations of STI-571/imatinib-sensitive kinases
(KIT, PDGFRA, PDGFRB) by denaturing HPLC and direct DNA sequencing.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28
days in the absence of disease progression, unacceptable toxicity, or symptomatic
deterioration.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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