This is a window opportunity study of propranolol in patients with angiosarcoma. The aim of this study is to prospectively evaluate the activity of propranolol in the clinical setting as monotherapy, where the neoadjuvant setting provides a good opportunity to rapidly evaluate both the clinical response and histological response, without a significant delay in anti-cancer treatment.
A pilot neoadjuvant window of opportunity study will be performed to explore the activity of propranolol monotherapy in angiosarcoma. The study consists of a single arm. Propranolol will be administred as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. When patients are diagnosed, standard anti-cancer treatment will be scheduled in 6 weeks while propranolol treatment can start immediately after diagnosis and will be continued until the day the standard anti-cancer treatment is started. The duration of treatment will therefore be 3-6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Propranolol will be administered as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. The study consists of a single arm.
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands
Clinical response
A response is defined as CR, PR, or SD with an improvement in clinical characteristics
Time frame: From start to end of treatment: 3-6 weeks
Histological response on propranolol treatment
The histologic response defined as a decrease of \>30% of Ki-67 index between pre- and post-propranolol treatment biopsies.
Time frame: through study completion, an average of 2 years
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