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| Sponsor: | Sarcoma Alliance for Research through Collaboration |
|---|---|
| Information provided by (Responsible Party): | 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: 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 |
| 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 |
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:
Contacts and 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 | |
| Principal Investigator: | Scott Schuetze, MD, PhD | University of Michigan |
More Information
| 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 |
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newly diagnosed or recurrent |
|
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 |