Dermatofibrosarcoma Protuberans
Conditions
Keywords
newly diagnosed or recurrent
Brief summary
The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.
Interventions
DRUGimatinib mesylate
400 mg orally twice a day for 10 - 14 days
Sponsors
Sarcoma Alliance for Research through Collaboration
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Imatinib | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Imatinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age Continuous | 49 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 2 / 18 |
Outcome results
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.
Time frame: Prior to and after 2-weeks of imatinib therapy
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Imatinib | 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. | 18 paired tumor tissue samples |