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Trial record 1 of 1 for:    N19PCA
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Propranolol in Angiosarcoma

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ClinicalTrials.gov Identifier: NCT04518124
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : December 21, 2021
Sponsor:
Collaborator:
Anticancer Fund, Belgium
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 27, 2019
Estimated Primary Completion Date : December 27, 2022
Estimated Study Completion Date : December 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518124


Contacts
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Contact: Alaa Embaby, MD +31 (0)20 5129111 a.embaby@nki.nl

Locations
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Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands
Contact: Alaa Embaby, MD    +31 (0)20 512 9111    a.embaby@nki.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Anticancer Fund, Belgium
Investigators
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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
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT04518124    
Other Study ID Numbers: N19PCA
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
Propranolol
Angiosarcoma
Additional relevant MeSH terms:
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Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Propranolol
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents