Propranolol in Angiosarcoma

  • STATUS
    Recruiting
  • End date
    Dec 27, 2021
  • participants needed
    14
  • sponsor
    The Netherlands Cancer Institute
Updated on 26 January 2021

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.

Details
Condition Hemangiosarcoma, Sarcoma, Sarcoma (Pediatric), Angiosarcoma of Skin, Soft Tissue Sarcoma, Angiosarcoma of the Breast, angiosarcoma
Treatment Propranolol
Clinical Study IdentifierNCT04518124
SponsorThe Netherlands Cancer Institute
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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 -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
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