Clinical Trial: Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Imatinib (NSC-716051) in Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans

Brief Summary: This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma). Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the response rate (confirmed complete and confirmed partial response) in patients with locally advanced or metastatic dermatofibrosarcoma protuberans (DFSP) treated with imatinib.

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 manner.

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.

OUTLINE:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Response rate (confirmed complete and confirmed partial response) [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: At 1 year ]
  • Frequency and severity of toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: Up to 5 years after completion of treatment ]
  • Relationship between PDGFB and survival [ Time Frame: At baseline and at the time of progression ]


Original Primary Outcome:

Current Secondary Outcome: Relationship between PDGFB and tumor response to imatinib mesylate [ Time Frame: Up to 5 years ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: June 10, 2004
Date Started: May 2004
Date Completion:
Last Updated: February 27, 2013
Last Verified: February 2013