Trial Outcomes & Findings for Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans (NCT NCT00243191)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Prior to and after 2-weeks of imatinib therapy

Results posted on

2012-03-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Imatinib
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib n=18 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	49 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Imatinib n=18 Participants
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

Adverse Events

Imatinib

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imatinib n=18 participants at risk
Cardiac disorders chest pain	5.6% 1/18 • Number of events 1 • 3 years, 6 months
Respiratory, thoracic and mediastinal disorders shortness of breath	5.6% 1/18 • Number of events 1 • 3 years, 6 months
Skin and subcutaneous tissue disorders infection	5.6% 1/18 • Number of events 1 • 3 years, 6 months
General disorders pain	5.6% 1/18 • Number of events 1 • 3 years, 6 months

Other adverse events

Adverse event data not reported

Additional Information

SARC, Chief Operating Officer

SARC

Phone: 734-930-7600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60