A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

Pts must have biopsy-proven diagnosis of Merkel Cell Carcinoma (Cutaneous Neuroendocrine Carcinoma) that is distantly metastatic or unresectable; Primary must be of skin origin and express c-kit (CD117) by DAKO antibody staining; Pts must have measurable disease by physical exam, CT/MRI or plain X-ray outside any prior radiation port unless clear progression is demonstrated prior to registration; Pts w/symptomatic, unstable or untreated brain metastases are not eligible; Previous treatment must have been completed 28 prior to registration; Prior radiotherapy, chemotherapy, biologic therapy or any other investigational drug is allowed, if completed at least 28 days prior to registration and recovered from toxicities; Zubrod PS 0-2; Serum Creatinine </= 1.5 x IULN; ANC >/= 1,000, PLTS >/= 100,000, hemoglobin >/= 9.0, bilirubin </= 3 X IULN; SGOT or SGPT </= IULN, unless liver is involved w/tumor, then must have SGOT or SGPT </= 5 x IULN; Pts must not have prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical ca, Stage I or II ca in complete remission and disease-free from any ca for 5 yrs; Pts must not have Class 3/4 Cardiac problems as defined by the New York Heart Association Criteria; Pts must not have severe and/or uncontrolled concurrent medical disease; pts must not be receiving therapeutic doses of coumadin (warfarin) at time of registration; Low molecular weight heparin (e.g., Lovenox) or other agent and mini-dose coumadin (1 mg po QD) allowed; Pts must not be pregnant or nursing or of reproductive potential and not agreed to use of effective barrier contraceptive method.
NOTE: Submission of specimens as outlined in Sections 15.1-15.3 is strongly encouraged.