Last updated on June 2019

Doxorubicin Eluting Intra-arterial Embolization for Aggressive Desmoid Fibromatosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Aggressive fibromatosis | Desmoid Neoplasm of Chest Wall | Desmoid Tumor Caused by Somatic Mutation | Desmoid Fibromatosis of Skin
  • Age: Between 3 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 3-80 years.
  2. Histologically confirmed diagnosis of Desmoids Fibromatosis.
  3. After at least one systemic treatment line. Standard first line systemic treatment may include: Methotrexate, Vinblastine, Doxorubicin, Liposomal Doxorubicin (Doxil), NSAIDS or hormonal treatment. If first line treatment is renounced, this treatment decision must be documented. Considering the trend of avoiding surgical treatment, the documentation must include that the treatment decision is not associated to the resectability of the tumor.
  4. Karnofsky performance status (PS)>50% for patients older than 16 years or Lansky PS >50% for patients under 16 years.
  5. At least one measurable lesion, with a long diameter of at least 30mm, with an anatomical location accessible for endovascular treatment.
  6. T2 signal increase on MRI.
  7. No evidence of prior treatment toxicity, adequate washout period after prior
    • 14 days after myelosuppressive chemotherapy treatment.
    • 7 days after GCSF (Granulocyte colony-stimulating factor), 14 days after Neulastim.
    • 7 days after targeted/biologic treatment.
  8. Female patients of childbearing potential must be willing to use an adequate method of contraception (hormonal, barrier or abstinence) for the treatment period and up to 90 days after the treatment completion.
  9. Willing and able to provide written informed consent for the trial.

Exclusion Criteria:

  1. Participation in another interventional study.
  2. Congestive heart failure, characterised by LVEF (Left Ventricular Ejection Fraction) < 50% or Shortening fracture < 27%.
  3. Previous treatment with anthracycline of a accumulative dose of more than 360 mg/m2.
  4. History of allergic reaction attributed to Doxil or doxorubicin treatment.
  5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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