Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

• 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: Sarcoma Alliance for Research through Collaboration
• Information provided by (Responsible Party): Sarcoma Alliance for Research through Collaboration

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dermatofibrosarcoma Protuberans	Drug: imatinib mesylate	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans
• Study Start Date: May 2006
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
imatinib mesylate	Drug: imatinib mesylate; 400 mg orally twice a day for 10 - 14 days; Other Name: Gleevec

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

SARC Website 

• Responsible Party: Sarcoma Alliance for Research through Collaboration
• ClinicalTrials.gov Identifier: NCT00243191
• Obsolete Identifiers: NCT00176709
• Other Study ID Numbers: SARC004
• First Posted: October 21, 2005
• Results First Posted: March 29, 2012
• Last Update Posted: March 29, 2012
• Last Verified: February 2012

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 Mesylate; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action