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Sponsored by: |
Sarcoma Alliance for Research through Collaboration |
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Information provided by: | Sarcoma Alliance for Research through Collaboration |
ClinicalTrials.gov Identifier: | NCT00243191 |
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 |
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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
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.
Exclusion criteria:
Contact: Denise K. Reinke, MS, NP, President | 734-930-7600 | sarc@sarctrials.org |
Contact: Kathleen Granlund | 734-930-7607 | kegranlund@sarctrials.org |
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University of Florida Health Science Center | Withdrawn |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 |
Principal Investigator: | Scott Schuetze, MD, PhD | University of Michigan |
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 |
newly diagnosed or recurrent |
Imatinib Dermatofibrosarcoma protuberans Neoplasms, Connective and Soft Tissue Fibrosarcoma Malignant mesenchymal tumor |
Sarcoma Dermatofibrosarcoma Soft tissue sarcomas Recurrence |
Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue |