Propranolol in Angiosarcoma

Related Clinical Trial

Brief Title

Propranolol in Angiosarcoma

Official Title

Neoadjuvant Trial on the Efficacy of Propranolol Monotherapy in Cutaneous Angiosarcoma

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Clinical response

Secondary Outcome

 Histological response on propranolol treatment

Condition

Angiosarcoma

Intervention

Propranolol

Study Arms / Comparison Groups

 Propranolol
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

December 27, 2019

Completion Date

December 27, 2021

Primary Completion Date

December 27, 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Winan van Houdt, MD PhD, +31 (0)20 5129111, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT04518124

Organization ID

N19PCA


Responsible Party

Sponsor

Study Sponsor

The Netherlands Cancer Institute

Collaborators

 Anticancer Fund, Belgium

Study Sponsor

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


Verification Date

November 2020