Doxorubin-eluting particle embolization for treatment of Desmoid Fibromatosis.

Desmoid

Desmoid Fibromatosis of Skin

Desmoid Neoplasm of Chest Wall

Desmoid Tumor Caused by Somatic Mutation

Aggressive Fibromatoses

Fibromatosis Desmoid

Desmoid Fibromatosis

Delivery of Doxorubicin selectively into Desmoid Fibromatosis utilizing its vascular supply as a conduit, and ionic loading the doxorubicin onto embolized particles as the drug delivery vehicle.
Maximal dose is 75 mg/m2 and at least 50 mg. The bead size is 75-300 Mµ in a 2 CC syringe.

Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis

Rabin Medical Center

Doxorubicin Eluting Intra-arterial Embolization for Aggressive Desmoid Fibromatosis

Response to treatment. Measured by change in tumor size according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria.

Response to treatment. Tumor biological activity measured by change in MRI T2 signal intensity.

Change in clinical symptoms measured by standard clinical patient questionnaires - EORTC QLQ-C30. (Quality of Life Questionnaire).
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high level of functioning, a high score for the global health status / QoL represents a high QoL. Similarly, a high score for a symptom scale represents a high level of symptomatology.

Treatment safety measured by standard patient questionnaires and clinical evaluation using CTCAE (Common Terminology Criteria for Adverse Events) version 5.0.

Measurements of blood Doxorubicin concentration (mg/ml) over time, after treatment.

Immunohistochemistry assay assessing the staining pattern (marked as negative to mildly or strongly positive) for: beta-catenin, keratin, SMA (smooth muscle actin). Ki-67 staining will be scored by percentage.

Eldad Elnekave, MD

Director, Clinic Interventional Oncology

Desmoid Tumor

Phase 1 : Imatinib 400mg QD P q28days Vactosertib 1 cohort 200mg bid (D1-5, 8-12, 15-19, 22-26)
1 cohort 100mg bid Phase 2 : Imatinib 400mg QD PO q28days. Vactosertib RP2D, bid (D1-5, 8-12, 15-19, 22-26)

vactosertib/imatinib combination

Severance Hospital, Yonsei University Health System

A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor

A Phase 1b/2a, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib in Combination With Imatinib in Patients With Advanced Desmoid Tumor (Aggressive Fibromatosis)

fibroma/tyrosine

Doxorubicin Eluting Intra-arterial Embolization for Aggressive Desmoid Fibromatosis

A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor

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