Propranolol in Angiosarcoma

Sponsor

The Netherlands Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04518124

Collaborator

Anticancer Fund, Belgium (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Angiosarcoma	Drug: Propranolol	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neoadjuvant Trial on the Efficacy of Propranolol Monotherapy in Cutaneous Angiosarcoma

Actual Study Start Date :

Dec 27, 2019

Anticipated Primary Completion Date :

Dec 27, 2022

Anticipated Study Completion Date :

Dec 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propranolol	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.

Arm

Intervention/Treatment

Experimental: Propranolol

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.

Outcome Measures

Primary Outcome Measures

Clinical response [From start to end of treatment: 3-6 weeks]
A response is defined as CR, PR, or SD with an improvement in clinical characteristics

Secondary Outcome Measures

Histological response on propranolol treatment [through study completion, an average of 2 years]
The histologic response defined as a decrease of >30% of Ki-67 index between pre- and post-propranolol treatment biopsies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological proof of angiosarcoma
Patients with primary, recurrent and metastasised disease are eligible;
Patients with a window of at least 3 weeks before surgery or systemic therapy;
Age ≥ 18 years;
Able and willing to give written informed consent;
WHO performance status of 0, 1 or 2;
Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma
Minimal acceptable safety laboratory values
ANC of ≥ 1.5 x 109 /L
Platelet count of ≥ 100 x 109 /L
Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 2.5 x ULN
Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula);
At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician

Exclusion Criteria:

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.
Current treatment with β-blockade therapy.
Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
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;
Pregnancy;
Legal incapacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Netherlands Cancer Institute - Antoni van Leeuwenhoek	Amsterdam		Netherlands

Sponsors and Collaborators

The Netherlands Cancer Institute
Anticancer Fund, Belgium

Investigators

Principal Investigator: Winan van Houdt, MD PhD, Netherlands Cancer Institute - Antoni van Leeuwenhoek
Principal Investigator: Neeltje Steeghs, MD PhD, Netherlands Cancer Institute - Antoni van Leeuwenhoek

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Netherlands Cancer Institute

ClinicalTrials.gov Identifier:

NCT04518124

Other Study ID Numbers:

N19PCA

First Posted:

Aug 19, 2020

Last Update Posted:

Dec 21, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Netherlands Cancer Institute

Propranolol

Angiosarcoma

Additional relevant MeSH terms:

Hemangiosarcoma

Propranolol

Study Results

No Results Posted as of Dec 21, 2021