A Pilot Study of Intralesional Injection of Triamcinolone Acetonide for Desmoid Tumors

NCT03627741 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 17-008766
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

There is research supporting treatment of superficial fibromatoses (palmar fibromatosis and keloids) with triamcinolone acetonide injections. These lesions are histologically similar to deep fibromatoses (desmoid tumors). Currently there is little literature evaluating the response of desmoid tumors to injections of triamcinolone acetonide. The investigators aim to perform a pilot study evaluating the response of desmoid tumors to intralesional triamcinolone. If positive results are observed (based on RECIST criteria), then a phase II study will be initiated.

Conditions

Fibromatosis

Outcome Measures

Primary Outcomes (4)

• Response rate of desmoid tumors to serial triamcinolone injections based on WHO criteria.

  Based on MRI imaging

  2 years

• Response rate of desmoid tumors to serial triamcinolone injections based on change in tumor volume.

  Based on MRI imaging

  2 years

• Response rate of desmoid tumors to serial triamcinolone injections based on change in T2 signaling hyperintensity.

  Based on MRI imaging

  2 years

• Response rate of desmoid tumors to serial triamcinolone injections based on RECIST.

  Based on MRI imaging

  2 years

Secondary Outcomes (2)

• Number patients experiencing a non-serious adverse event following triamcinolone injections.

  6 months following initial administration of triamcinolone injections

• Number of patients experiencing a serious adverse event following triamcinolone injections.

  6 months following initial adminstration of triamcinolone injections.

Study Arms (1)

Triamcinolone arm

EXPERIMENTAL

A concentration of 40 mg/ml of Triamcinolone Acetonide will be used for injections with a total dose of 120 mg of Triamcinolone given per injection. The injections will be performed under ultrasound guidance by a fellowship-trained musculoskeletal radiologist. The injection locations will be left to the discretion of the radiologist with the request to attempt to distribute the drug throughout the tumor. A total of three injections will be performed at six week intervals.

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

A concentration of 40 mg/ml of Triamcinolone Acetonide will be used for injections with a total dose of 120 mg of Triamcinolone given per injection. The injections will be performed under ultrasound guidance by a fellowship-trained musculoskeletal radiologist. The injection locations will be left to the discretion of the radiologist with the request to attempt to distribute the drug throughout the tumor. A total of three injections will be performed at six week intervals.

Triamcinolone arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to sign an informed consent form.
• Willing to comply with protocol procedures including required 21 month follow up after last injection.

You may not qualify if:

• 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; (a) 10% when comparing a prior CT scan to a current MRI, or (b) 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fibroma

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Benjamin K Wilke, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 13, 2018
• Study Start: June 7, 2018
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

US (1)