A Phase II Study of Imatinib (NSC-716051) in Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
I. To assess the response rate (confirmed complete and confirmed partial response) in
patients with locally advanced or metastatic dermatofibrosarcoma protuberans (DFSP) treated
II. To estimate the one-year progression-free survival probability in this population when
treated with imatinib.
III. To evaluate the frequency and severity of toxicities associated with this treatment.
IV. To measure the presence of PDGFB gene rearrangement in DFSP detectable by RT-PCR (for
COL1A1-PDGFB fusions) and/or FISH (PDGFB rearrangements with unknown partners) and explore
relationships between these measures and survival and tumor response in a preliminary
V. To investigate in a preliminary fashion the correlation of plasma levels of imatinib
after 1 month of treatment with the response of DFSP.
VI. To obtain tumor material for additional future correlative studies of the activity of
intracellular kinases, cDNA microarray analyses and PDGFB receptor gene sequence analyses.
Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56
days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients
with documented tumor progression and no serious side effects may continue therapy at a
higher dose for another 6 courses.
Patients are followed every 6 months for 2 years and then annually for 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (confirmed complete and confirmed partial response)
Up to 5 years
Southwest Oncology Group
United States: Food and Drug Administration
|Southwest Oncology Group||San Antonio, Texas 78245|