Clinical trial NCT00085475 (phase 2, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
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:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma

               -  Locally advanced or metastatic disease

          -  Measurable disease

          -  Not amenable to surgery, radiotherapy, or combined modality therapy with curative
             intent

          -  Documented progressive disease within the past 3 months

               -  Previously irradiated lesions must show disease progression

          -  Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization

               -  Translocation t(17;22)(q22;q13)

          -  No prior chemotherapy OR previously treated with 1, and only 1, line of combination
             chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR
             relapsed within 6 months after adjuvant chemotherapy

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 2,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 mg/dL* NOTE: *Transfusion allowed

        Hepatic

          -  SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic
             metastases are present)

          -  Bilirubin ≤ 1.5 times ULN

          -  No uncontrolled hepatic disease

        Renal

          -  Creatinine ≤ 1.5 times ULN

          -  No uncontrolled renal disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  HIV negative

          -  No uncontrolled diabetes

          -  No active or uncontrolled infection

          -  No concurrent severe or uncontrolled medical disease

          -  No medical, psychological, familial, sociological, or geographical condition that
             would preclude study participation, compliance, or giving informed consent

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer currently in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 28 days since prior biologic therapy

          -  No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

          -  No concurrent anticancer biologic agents

        Chemotherapy

          -  See Disease Characteristics

          -  More than 28 days since prior chemotherapy

          -  No concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 6 months since prior radiotherapy

          -  No concurrent radiotherapy

               -  Concurrent palliative radiotherapy allowed provided radiotherapy will not be
                  administered to a target lesion

        Surgery

          -  Not specified

        Other

          -  More than 28 days since prior investigational drugs

          -  No concurrent therapeutic anticoagulation therapy with warfarin

               -  Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of
                  central venous catheter thrombosis allowed

          -  No other concurrent anticancer agents

          -  No other concurrent investigational drugs

          -  No other concurrent cytostatic agents

          -  No other concurrent tyrosine kinase inhibitors