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Trial record 2 of 20 for:    "dermatofibrosarcoma protuberans"

Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

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ClinicalTrials.gov Identifier: NCT00243191
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Dermatofibrosarcoma Protuberans
Intervention Drug: imatinib mesylate
Enrollment 18
Recruitment Details Recruitment period began May 1, 2006 and was completed July 22, 2009. There were 5 SARC sites participating. SARC sites are primarily academic institutions with Sarcoma programs.
Pre-assignment Details  
Arm/Group Title Imatinib
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Imatinib
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  88.9%
>=65 years
2
  11.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
49  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
10
  55.6%
Male
8
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Prior to and after 2-weeks of imatinib therapy
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Hide Analysis Population Description
Population of paired tissue samples collected from patients with confirmed diagnosis of dermatofibrosarcoma protuberans. Tissue sample will be considered evaluable if there is adequate pre-treatment and on-treatment tumor tissue available for the proposed molecular studies, and resection of DFSP was completed after receiving imatinib.
Arm/Group Title Imatinib
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: paired tumor tissue samples
18
Time Frame 3 years, 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imatinib
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All-Cause Mortality
Imatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Imatinib
Affected / at Risk (%) # Events
Total   2/18 (11.11%)    
Cardiac disorders   
chest pain  1  1/18 (5.56%)  1
General disorders   
pain  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
shortness of breath  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
infection  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imatinib
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Dermatofibrosarcoma protuberans (DFSP)is a rare tumor type. During the the trial the drug manufacturer obtained approval for DSFP indication.The other limitation is limited funding; SARC is actively seeking funding for secondary outcome goal 12/2012.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: SARC, Chief Operating Officer
Organization: SARC
Phone: 734-930-7600
Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00243191     History of Changes
Obsolete Identifiers: NCT00176709
Other Study ID Numbers: SARC004
First Submitted: October 20, 2005
First Posted: October 21, 2005
Results First Submitted: March 14, 2011
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012