Clinical Trials Directory

Trials / Completed

CompletedNCT00084630

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
40 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGimatinib mesylateGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2004-05-01
Primary completion
2007-07-01
First posted
2004-06-11
Last updated
2013-02-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00084630. Inclusion in this directory is not an endorsement.