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

Phase 2
18 Years
Not Enrolling
Adult Fibrosarcoma, Dermatofibrosarcoma Protuberans, Recurrent Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

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Trial Information

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
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

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.

Inclusion Criteria:

- Patients must have histologically confirmed diagnosis of either dermatofibrosarcoma
protuberans (DFSP) or transformed fibrosarcomatous DFSP; patients with transformed
fibrosarcomatous DFSP may have primary, locally recurrent or metastatic disease;
patients with DFSP must have locally recurrent or metastatic disease OR primary
disease for which complete excision with a wide margin (> 1-2 cm) would result in
unacceptable cosmetic disfigurement or functional impairment

- Patients must have measurable disease; x-rays, scans or physical examinations used
for tumor measurement must have been completed within 28 days prior to registration;
x-rays, scans or other tests for assessment of non-measurable disease must have been
performed within 42 days prior to registration; all disease must be assessed

- Pathology materials must be submitted for review; failure to submit pathology
materials will render the patient ineligible

- Patients must be willing to have blood samples submitted for testing of drug levels;
also, it is strongly recommended that patients submit fresh/frozen tumor tissue that
will yield 0.5 grams (0.5 cubic centimeters) for molecular correlative studies
related to the PDGFR pathway

- Patient must not have had chemotherapy, biologic therapy or investigational agents
for this tumor within 28 days prior to registration

- Patients may have received prior major surgery for this disease; at least 14 days
must have elapsed since the surgery and the patient must have recovered from all side
effects associated with surgery; biopsy of dermatofibrosarcoma protuberans is not
considered major surgery and a 14-day delay after biopsy is not required

- Prior radiotherapy is allowed, provided at least four weeks have elapsed since the
last treatment, there is evidence of progressive disease within or measurable disease
outside of the radiation field, and the patient must have recovered from all
associated toxicities at the time of registration

- Patients must have Zubrod performance status of =< 2

- WBC >= 2,000/uL

- ANC >= 1,500/uL

- Platelets >= 100,000/uL

- Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN)

- Serum transaminase (SGOT or SGPT) must be =< 2.5 x IULN

- Serum albumin must be >= 2.5 mg/dl

- Patients must not be taking therapeutic doses of coumadin (Warfarin) at the time of
registration; patients requiring therapeutic anticoagulation may use heparin, low
molecular weight heparin or other agents; mini-dose coumadin (1 mg orally every day
as prophylaxis is allowed

- Patients with known CNS metastases are not eligible

- Pregnant or nursing women may not participate on this study; there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with imatinib; male/female patients of reproductive potential must also agree
to employ an effective contraceptive barrier method of birth control throughout the
study and for up to 3 months following discontinuation of study drug

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

- At the time of patients registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
have been entered into the database

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (confirmed complete and confirmed partial response)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Scott Schuetze

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Adult Fibrosarcoma
  • Dermatofibrosarcoma Protuberans
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Fibrosarcoma
  • Dermatofibrosarcoma
  • Sarcoma



Southwest Oncology Group San Antonio, Texas  78245