Overview

Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dermatologic Cooperative Oncology Group
Treatments:
Imatinib Mesylate
Criteria
Inclusion Criteria:

- Histological diagnosis of primary or recurrent dermatofibrosarcoma protuberans

- Measurable tumor parameters (by magnetic resonance imaging [MRI])

- Patient >/= 18 years of age

- ECOG performance status < 3

- Adequate organ function

- Patients must be able to swallow capsules

- Female patients of childbearing potential must have negative pregnancy test

- Written, voluntary, informed consent; must include investigational use of tumor tissue
biopsies.

Exclusion Criteria:

- Any evidence of distant metastases

- Patient has received any other investigational agents within 28 days of first day of
study drug dosing

- Patient is < 5 years free of another primary malignancy except basal cell skin cancer
or cervical carcinoma in situ

- Grade III/IV cardiac problems as defined by the New York Heart Association

- Severe and/or uncontrolled medical disease

- Known diagnosis of human immunodeficiency virus (HIV) infection