Propranolol in Angiosarcoma

November 21, 2023 updated by: The Netherlands Cancer Institute

Neoadjuvant Trial on the Efficacy of Propranolol Monotherapy in Cutaneous Angiosarcoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alaa Embaby, MD
  • Phone Number: +31 (0)20 5129111
  • Email: a.embaby@nki.nl

Study Locations

      • Amsterdam, Netherlands
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 β-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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: From start to end of treatment: 3-6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological response on propranolol treatment
Time Frame: 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.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2019

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • N19PCA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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