A Study to Evaluate Intralesional Injection of Triamcinolone Acetonide to Treat Desmoid Tumors

Overview

About this study

The purpose of this study is to determine the response of desmoid tumors to intralesional injections of triamcinolone acetonide.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients with histologically confirmed diagnosis of extra-abdominal aggressive fibromatosis (desmoid tumor).
  • At least one of the following:
    • Desmoid tumor that has shown stability in size over consecutive axial imaging (CT or MRI) at least 3 months apart; AND
    • Presence of any tumor-related symptoms; OR
    • An increase in size based on consecutive axial imaging (CT or MRI). Additionally, for patients with a desmoid tumor which has been irradiated, at least a 10% increase in size by volume since receiving radiotherapy is required.
  • ECOG Performance status of ≤ 1.
  • Able to participate in three guided injection procedures.
  • Able to undergo a MRI with and without contrast of the tumor site.
  • Age ≥ 18 years and ≤ 89 years old.
  • Willing to sign an informed consent form.
  • Willing to comply with protocol procedures including required 21 month follow up after last injection.

Exclusion Criteria:

  • Allergy to the test drug or a component of its formulation.
  • Patients with a desmoid tumor which has been stable in size and without symptoms or decreased in size over the prior three months utilizing axial imaging according to the following criteria:
    • 10% when comparing a prior CT scan to a current MRI; or
    • more than 5% when comparing a prior MRI to a current MRI.
  • The patient must not be on anticoagulation (aspirin okay).
  • The patient should not be pregnant or trying to become pregnant, and willing to use adequate contraception during study participation to avoid pregnancy.
  • The patient should not be breastfeeding.
  • Active infection that in the opinion of the investigator compromises the patient’s participation (i.e., a UTI is ok).
  • A diagnosis of idiopathic thrombocytopenia purpura.
  • Undergoing concomitant treatment (including radiation, systemic treatment, surgery, or other tumor directed therapy). The patient must be off of the systemic therapy for a period of at least 5 drug half-lives prior to enrolling in the study.
  • Uncontrolled or poorly controlled diabetes mellitus.
  • Has an uncontrolled  illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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