Health TrialsbyHealthPanel

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer. All participants in this study will receive an experimental treatment made up of focused ultrasound ablation (FUSA), a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue, and an injection in the tumor with an experimental drug that activates the immune system called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine). Neither the drug nor the device that are used in this study have been approved by the U.S. Food and Drug Administration (FDA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Diagnosis of advanced melanoma planned for surgical resection.

Focused Ultrasound Ablation (FUSA): The targeted lesion(s) must be visible by ultrasound imaging and meet the following criteria.

Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA.

Disqualifiers

Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)

Allergy desensitization injections

Daily doses of 10 mg or less prednisone (or equivalent) per day administered parenterally or orally are allowed in patients with normal adrenal and pituitary function.

In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed.

Trial design

Design model

Single group

Treatments tested in this trial

  • Echopulse or Echopulse HD

    Device

    The Echopulse/Echopulse HD device delivers focused ultrasound ablation (FUSA) therapy. FUSA is a technology that delivers continuous high-intensity focused ultrasound to ablate (heat and destroy) tissue. A series of sound waves will be focused on the tumor using the Echopulse or the Echopulse HD device to cover the planned target area. The targeted area is 33% of the tumor, up to 3.5 cubic centimeters. An ultrasound will be used to guide the beam of the FUSA treatment to the targeted site. FUSA will be applied to up to two tumors in the session. Participants are sedated during the FUSA treatment.

  • PolyICLC

    Drug

    PolyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine) is a drug that may help the body build an effective immune response to kill tumor cells. A single injection of .9 mg of polyICLC into one tumor will be given within 4 hours after the FUSA.

Treatment groups

11 Participants
are divided into 1 treatment group
Group A: FUSA + polyICLCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Events

Incidence and severity of adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\] v5).

Time frame
Collected from Day 1 up to Day 22
2

Pathologic ablation zone

Proportion of patients where the size of the pathologic ablation zone is within 20% of the planned zone

Time frame
Day 22

Secondary outcomes

1

Presence of Periablation Zone

Proportion of participants with a zone of tissue with live vasculature, fibrosis, and a histiocytic reaction as determined by hematoxylin and eosin (H\&E) staining and/or immunohistochemistry

Time frame
Day 22

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Theraclion

Collaborator

Source ClinicalTrials.gov
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