Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans
Condition: Dermatofibrosarcoma Protuberans
MeSH terms: Dermatofibrosarcoma
Intervention: imatinib mesylate
Intervention description: 400 mg orally twice a day for 10 - 14 days
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: newly diagnosed or recurrent

Summary:

      The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma
      protuberan tumors.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients ≥ or equal to 18 years of age.

          2. Suspected or documented diagnosis of dermatofibrosarcoma protuberans (DFSP). Patients
             with suspected diagnosis of DSFP must have DFSP confirmed by pathology at the local
             institution prior to dispensing and the start of imatinib.

          3. Patient is medically able to undergo surgical resection of the DFSP and resection of
             the DFSP is recommended for clinical management of the disease.

          4. Patient has at least one site of measurable (macroscopic) disease.

          5. Performance status 0, 1 or 2 Eastern Cooperative Oncology Group (ECOG) (see Section
             7.1).

          6. Adequate end organ function, defined as the following:

             total bilirubin < 1.5 x institutional upper limit of normal (ULN), SGOT and SGPT < 2.5
             x UNL, creatinine < 1.5 x ULN, absolute neutrophil count > 1.5 x 109/L, platelets >
             100 x 109/L.

          7. Female patients of childbearing potential must have negative pregnancy test within 7
             days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
             for at least 12 months to be considered of non-childbearing potential. Male and female
             patients of reproductive potential must agree to employ an effective barrier method of
             birth control throughout the study and for up to 3 months following discontinuation of
             study drug.

          8. Written, voluntary informed consent.

        Exclusion criteria:

          1. Patients who will receive radiation therapy to the site of DFSP prior to resection.

          2. Patients with Grade III/IV cardiac problems as defined by the New York Heart
             Association Criteria (i.e., congestive heart failure, myocardial infarction within 6
             months of study).

          3. Female patients who are pregnant or breast-feeding.

          4. Patients who have a severe and/or uncontrolled medical disease (i.e., uncontrolled
             diabetes, chronic renal disease, or active uncontrolled infection) that may worsen
             because of imatinib.

          5. Patients who have known chronic liver disease (i.e., chronic active hepatitis, and
             cirrhosis).

          6. Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection.

          7. Patients who have received chemotherapy within 4 weeks prior to study entry.

          8. Patients who have had a major surgery within 2 weeks prior to study entry. Incisional
             biopsy or partial excision of dermatofibrosarcoma protuberans to establish the
             diagnosis and/or to collect pretreatment tumor tissue does not qualify as major
             surgery.