Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

Dermatofibrosarcoma Protuberans Clinical Trial

Official title:

Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243191
• Other study ID #: SARC004
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2005
• Last updated: February 14, 2012
• Start date: May 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2012
• Source: Sarcoma Alliance for Research through Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00176709

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dermatofibrosarcoma
• Dermatofibrosarcoma Protuberans

Intervention

Drug:
• imatinib mesylate
400 mg orally twice a day for 10 - 14 days

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Pennsylvania Onc/Hem Assoc.	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sarcoma Alliance for Research through Collaboration

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Prior to and after 2-weeks of imatinib therapy	No

External Links

•   SARC Website