A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans

Histologically confirmed DFSP or transformed fibrosarcomatous DFSP. Pts with transformed firbrosarcomatous DFSP may have primary, locally recurrent or metastatic dz. Pts with DFSP must have locally recurrent or metastatic dz OR primary dz for which complete excision with wide margin (>1-2 cm) would result in unacceptable cosmetic disfigurement or functional impairment. Measurable dz. Must submit pathology materials and blood samples. No chemotherapy, biologic therapy or investigational agents for this tumor within 28 days prior to registration. At least 14 days must have elapsed since any major surgery and must have recovered from all effects. At least four weeks must have elapsed since radiation therapy, patient must have recovered from all effects, and there must be evidence of progressive dz within or measurable dz outside the radiation field. Zubrod performance status 0-2. WBC greater than or equal to 2,000/ìl; ANC greater than or equal to 1,000/ìl; platelets greater than or equal to 100,000/ìl; serum bilirubin less than or equal to 1.5xIULN; SGOT/SGPT less than or equal to 2.5xIULN; serum albumin greater than or equal to 2.5 gm/dl. At least 18 years of age. Must not be taking therapeutic doses of coumadin. No known CNS metastases. No pregnant or nursing women. Pts of reproductive potential must agree to employ effective contraceptive barrier method of birth control throughout study and for up to 3 months following discontinuation of study drug. No other prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which pt is currently in complete remission, or any other cancer from which pt has been disease-free for 5 years.