Clinical Trials

Focused Ultrasound and Gemcitabine in Breast Cancer (Breast 54)

Status: Active, recruiting

This study tests the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We are testing the effects of each of these regimens on cells in the immune system. We hypothesize that the combination of focused ultrasound ablation and gemcitabine will decrease myeloid-derived suppressor cells and will increase T cell activity. We also hypothesize that focused ultrasound ablation and low-dose gemcitabine will be safe and will result in non-inferior surgical completion rates and tumor margin assessments.

Contact: Olena Glushakova; 434-409-6206; mailto:OYG2N at hscmail.mcc.virginia.edu

Principal Investigator: Patrick Dillon, MD

Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors (AM-003)

Status: Active, recruiting

This study evaluates whether it is safe to apply focused ultrasound, with and without PD-1 blockade, and with and without imiquimod. A focused ultrasound device called the Echopulse will be used for the therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with imiquimod, which is a topical TLR7 agonist.

Contact: Adela Mahmutovic; 434-982-6714; am6bd at hscmail.mcc.virginia.edu

Principal Investigator: Lynn Dengel, MD. MSc

Collaborator: Craig L Slingluff, Jr, MD

Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer (Breast-48)

Status: Active, recruiting

This pilot study evaluates the use of focused ultrasound combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after focused ultrasound and one-half of participants will be randomized to receive their first dose of pembrolizumab before focused ultrasound.

Contact: Adela Mahmutovic; 434-982-6714; am6bd at hscmail.mcc.virginia.edu

Contact: Rupert Egan; 434-982-1901; rje5k at hscmail.mcc.virginia.edu

Principal Investigator: Patrick Dillon, MD

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption

Status: Active, not recruiting

This is a prospective, multi-center, single-arm study to establish the safety and feasibility of BBB (blood brain barrier) disruption along the periphery of tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system. For this study, patients will be eligible to enroll in the study prior to beginning the planned adjuvant TMZ chemotherapy phase of treatment. Of note, only patients who are deemed eligible for adjuvant TMZ will be eligible for enrollment.