Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT00243191
First received: October 20, 2005
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Dermatofibrosarcoma Protuberans
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans

Resource links provided by NLM:


Further study details as provided by Sarcoma Alliance for Research through Collaboration:

Primary Outcome Measures:
  • To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies. [ Time Frame: Prior to and after 2-weeks of imatinib therapy ] [ Designated as safety issue: No ]
    To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.


Enrollment: 18
Study Start Date: May 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
imatinib mesylate Drug: imatinib mesylate
400 mg orally twice a day for 10 - 14 days
Other Name: Gleevec

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243191

Locations
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
Pennsylvania Onc/Hem Assoc.
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Investigators
Principal Investigator: Scott Schuetze, MD, PhD University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00243191     History of Changes
Obsolete Identifiers: NCT00176709
Other Study ID Numbers: SARC004
Study First Received: October 20, 2005
Results First Received: March 14, 2011
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sarcoma Alliance for Research through Collaboration:
newly diagnosed or recurrent

Additional relevant MeSH terms:
Dermatofibrosarcoma
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014