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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria

1. Patients with histologically confirmed diagnosis of extra-abdominal aggressive fibromatosis (desmoid tumor).

2. 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.

3. ECOG Performance status of < 1.

4. Able to participate in three guided injection procedures.

5. Able to undergo a MRI with and without contrast of the tumor site.

6. Age > 18 years and ≤ 89 years.

7. Willing to sign an informed consent form.

8. Willing to comply with protocol procedures including required 21 month follow up after last injection.

Exclusion Criteria

1. Allergy to the test drug or a component of its formulation

2. 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.

3. The patient must not be on anticoagulation (Aspirin okay)

4. The patient should not be pregnant or trying to become pregnant, and willing to use adequate contraception during study participation to avoid pregnancy

5. The patient should not be breastfeeding

6. Active infection that in the opinion of the investigator compromises the patient's participation (i.e., a UTI is ok)

7. A diagnosis of idiopathic thrombocytopenia purpura

8. 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.

9. Uncontrolled or poorly controlled diabetes mellitus

10. 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