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Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans
This study is currently recruiting participants.
Verified by Sarcoma Alliance for Research through Collaboration, December 2008
Sponsored by: Sarcoma Alliance for Research through Collaboration
Information provided by: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00243191
  Purpose

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


Condition Intervention Phase
Dermatofibrosarcoma Protuberans
Drug: imtatinib mesylate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans

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

Primary Outcome Measures:
  • Comparison of PDGFRB in tumor sample obtained prior to imatinib with sample obtained following 2 weeks of imatinib therapy [ Time Frame: Prior to and after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2005
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: imtatinib mesylate
    Dosing = 10-14 days prior to surgery
  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 (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

Contacts
Contact: Denise K. Reinke, MS, NP, President 734-930-7600 sarc@sarctrials.org
Contact: Kathleen Granlund 734-930-7607 kegranlund@sarctrials.org

Locations
United States, Florida
University of Florida Health Science Center Withdrawn
Gainesville, Florida, United States, 32610
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Susan Rivers, RN, OCN, CCRP     813-745-3558     susan.rivers@moffitt.org    
Principal Investigator: Jonathan Zager, MD            
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Andi Peshkepija     734-936-2712     andip@med.umich.edu    
Principal Investigator: Scott Schuetze, MD, PhD            
United States, Pennsylvania
Pennsylvania Onc/Hem Assoc. Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Deb Riordan     215-829-6712     debbieriordan@pennoncology.com    
Principal Investigator: Arthur Staddon            
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sylvia Abanto     713-794-1919     ssabanto@mdanderson.org    
Contact: Diane Gravel, RN     713-563-6702     dgravel@mdanderson.org    
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Investigators
Principal Investigator: Scott Schuetze, MD, PhD University of Michigan
  More Information

SARC Website  This link exits the ClinicalTrials.gov site

Responsible Party: SARC ( Denise Reinke, MS, NP, President )
Study ID Numbers: SARC004
Study First Received: October 20, 2005
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00243191  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Imatinib
Dermatofibrosarcoma protuberans
Neoplasms, Connective and Soft Tissue
Fibrosarcoma
Malignant mesenchymal tumor
Sarcoma
Dermatofibrosarcoma
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on January 13, 2009