Propranolol in Angiosarcoma

Angiosarcoma Clinical Trial

Official title:

Neoadjuvant Trial on the Efficacy of Propranolol Monotherapy in Cutaneous Angiosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518124
• Other study ID #: N19PCA
• Status: Completed
• Phase: Phase 2
• Start date: December 27, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histological proof of angiosarcoma

2. Patients with primary, recurrent and metastasised disease are eligible;

3. Patients with a window of at least 3 weeks before surgery or systemic therapy;

4. Age = 18 years;

5. Able and willing to give written informed consent;

6. WHO performance status of 0, 1 or 2;

7. Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma

8. Minimal acceptable safety laboratory values

9. ANC of = 1.5 x 109 /L

10. Platelet count of = 100 x 109 /L

11. Hepatic function as defined by serum bilirubin = 1.5 x ULN, ASAT and ALAT = 2.5 x ULN

12. Renal function as defined by serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min (by Cockcroft-Gault formula);

13. At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician

Exclusion Criteria:

1. Contraindication for propranolol therapy, like severe hypotension or bradycardia, sicksinus syndrome, second or third grade heart block, cardiogenic shock, untreated heart failure, severe peripheral vascular disease asthma or other obstructive lung diseases, untreated pheochromocytoma, metabolic acidosis, prolonged fasting.

2. Current treatment with ß-blockade therapy.

3. Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.

4. Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.

5. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;

6. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications;

7. Pregnancy;

8. Legal incapacity

Related Conditions & MeSH terms

• Angiosarcoma

Intervention

Drug:
• Propranolol
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.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Anticancer Fund, Belgium

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	A response is defined as CR, PR, or SD with an improvement in clinical characteristics	From start to end of treatment: 3-6 weeks
Secondary	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.	through study completion, an average of 2 years