Doxorubicin Eluting Intra-arterial Embolization for Aggressive Desmoid Fibromatosis

  • STATUS
    Recruiting
  • End date
    Oct 23, 2025
  • participants needed
    50
  • sponsor
    Rabin Medical Center
Updated on 23 January 2021
Investigator
Eldad Elnekave, MD
Primary Contact
Rabin Medical Center (0.0 mi away) Contact
methotrexate
measurable disease
nonsteroidal anti-inflammatory drugs
myelosuppressive chemotherapy
colony stimulating factors
vinblastine
fibromatosis

Summary

In this study Drug-eluting microbeads (DEB) loaded with Doxorubicin will be delivered into the target Desmoid Fibromatoses (DF) tissue via selective arterial embolization by angiographic technique. The objective of the study is to demonstrate the safety and efficacy of this treatment.

Description

Desmoid Fibromatoses (DF) are locally aggressive lesions associated with substantial morbidity and potentially mortality, due to invasion of adjacent neurovascular structures and vital organs. They have no potential for metastasis. Histologically, they are characterised by mature fibroblasts within a matrix of abundant fibrous stroma. While 5-15% of cases are seen in patients with Familial Adenomatous Polyposis (FAP) syndrome, the vast majority arise sporadically.

The etiology of Desmoids remains poorly understood and the therapeutic approaches in their management remain very diverse. For resectable lesions, surgery is recommended but reported cure rates range broadly from 12-80%. Systemic treatments range from non-steroidal anti-inflammatories and anti-estrogenic therapy to targeted tyrosine kinase inhibitors and cytotoxic chemotherapy, most commonly methotrexate, vinblastine and doxorubicin.

Doxorubicin is an anthracycline with demonstrated efficacy in treating desmoids at systemic IV doses of 50- 75mg/m2 over 3-4 week cycles. Extended use is limited by dose - dependent cardiotoxicity which can be seen in up to 36% of patients receiving doses in excess of 550mg/m2. Delayed cardiotoxicity is particularly common and less predictable among pediatric cancer survivors.

Selective trans-arterial chemo-embolization (TACE) is a method to achieve high tissue drug concentration with minimal systemic toxicity. Historically, this has been achieved by mixing doxorubicin with embolic agents such as lipiodol or gelatin sponge in the treatment of hepatocellular carcinoma (HCC).

Drug-eluting microbeads (DEB) ionically loaded with doxorubicin have shown sustained release in TACE target tissues with substantially lower serum drug concentrations when compared to lipiodol TACE.

The present study utilizes DEB's loaded with Doxorubicin delivered into the target DF tissue via selective arterial embolization by angiographic technique. This study follows a successful feasibility study.

Details
Condition Aggressive fibromatosis, Desmoid Tumors, Desmoid Fibromatosis of Skin, Desmoid Neoplasm of Chest Wall, Desmoid Tumor Caused by Somatic Mutation, desmoid tumor
Treatment Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis
Clinical Study IdentifierNCT03966742
SponsorRabin Medical Center
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 3-80 years
Histologically confirmed diagnosis of Desmoids Fibromatosis
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
Karnofsky performance status (PS)>50% for patients older than 16 years or Lansky PS >50% for patients under 16 years
At least one measurable lesion, with a long diameter of at least 30mm, with an anatomical location accessible for endovascular treatment
T2 signal increase on MRI
No evidence of prior treatment toxicity, adequate washout period after prior
treatment
days after myelosuppressive chemotherapy treatment
days after GCSF (Granulocyte colony-stimulating factor), 14 days after Neulastim
days after targeted/biologic treatment
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
Willing and able to provide written informed consent for the trial

Exclusion Criteria

Participation in another interventional study
Congestive heart failure, characterised by LVEF (Left Ventricular Ejection Fraction) < 50% or Shortening fracture < 27%
Previous treatment with anthracycline of a accumulative dose of more than 360 mg/m2
History of allergic reaction attributed to Doxil or doxorubicin treatment
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
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