Clinical trial NCT00084630 (phase 2, status: completed)
Conditions: adult fibrosarcoma, dermatofibrosarcoma protuberans, recurrent adult soft tissue sarcoma, stage iv adult soft tissue sarcoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: imatinib mesylate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed diagnosis of either dermatofibrosarcoma
             protuberans (DFSP) or transformed fibrosarcomatous DFSP; patients with transformed
             fibrosarcomatous DFSP may have primary, locally recurrent or metastatic disease;
             patients with DFSP must have locally recurrent or metastatic disease OR primary
             disease for which complete excision with a wide margin (> 1-2 cm) would result in
             unacceptable cosmetic disfigurement or functional impairment

          -  Patients must have measurable disease; x-rays, scans or physical examinations used for
             tumor measurement must have been completed within 28 days prior to registration;
             x-rays, scans or other tests for assessment of non-measurable disease must have been
             performed within 42 days prior to registration; all disease must be assessed

          -  Pathology materials must be submitted for review; failure to submit pathology
             materials will render the patient ineligible

          -  Patients must be willing to have blood samples submitted for testing of drug levels;
             also, it is strongly recommended that patients submit fresh/frozen tumor tissue that
             will yield 0.5 grams (0.5 cubic centimeters) for molecular correlative studies related
             to the PDGFR pathway

          -  Patient must not have had chemotherapy, biologic therapy or investigational agents for
             this tumor within 28 days prior to registration

          -  Patients may have received prior major surgery for this disease; at least 14 days must
             have elapsed since the surgery and the patient must have recovered from all side
             effects associated with surgery; biopsy of dermatofibrosarcoma protuberans is not
             considered major surgery and a 14-day delay after biopsy is not required

          -  Prior radiotherapy is allowed, provided at least four weeks have elapsed since the
             last treatment, there is evidence of progressive disease within or measurable disease
             outside of the radiation field, and the patient must have recovered from all
             associated toxicities at the time of registration

          -  Patients must have Zubrod performance status of =< 2

          -  WBC >= 2,000/uL

          -  ANC >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN)

          -  Serum transaminase (SGOT or SGPT) must be =< 2.5 x IULN

          -  Serum albumin must be >= 2.5 mg/dl

          -  Patients must not be taking therapeutic doses of coumadin (Warfarin) at the time of
             registration; patients requiring therapeutic anticoagulation may use heparin, low
             molecular weight heparin or other agents; mini-dose coumadin (1 mg orally every day as
             prophylaxis is allowed

          -  Patients with known CNS metastases are not eligible

          -  Pregnant or nursing women may not participate on this study; there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with imatinib; male/female patients of reproductive potential must also agree
             to employ an effective contraceptive barrier method of birth control throughout the
             study and for up to 3 months following discontinuation of study drug

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for 5 years

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patients registration, the treating institution's name and ID number
             must be provided to the Data Operations Center in Seattle in order to ensure that the
             current (within 365 days) date of institutional review board approval for this study
             have been entered into the database