CLINICAL CORNER

Kidney Cancer: Decrease the Temperature, Raise Awareness

From kayaking through the Everglades to backpacking around the Grand Canyon, 61-year-old Bob Wisneski enjoys adventuring around the country and embracing the outdoors.

Bob thrives in warm weather, yet freezing temperatures changed his life when he was 59 years old.

While at an appointment to address his gastroesophageal reflux disease (GERD) in 2019, Bob’s primary care doctor sent him for a variety of scans. Incidentally, the CT scan of his abdomen revealed a spot on his kidney. Bob’s physician referred him to Padraic O’Malley, MD, MSc, FRCSC, as he was championed “as the premiere urologist to see.”

O’Malley, a urology surgeon at UF Health, confirmed the spot to be a stage 1 tumor of 1.1 centimeters, and Bob’s kidney cancer treatment journey began.

They discussed the options. They could observe it. They could surgically remove it. They could treat it with percutaneous cryoablation.

“Percutaneous cryoablation is essentially like a freeze gun for kidney masses,” O’Malley said. “When the masses are small, cryoablation is essentially as effective as surgery to remove the tumor but less invasive, less risky and has a quicker recovery time.”


New Clinical Trials Open for Enrollment

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

A Phase 2, open-label, non-randomized study evaluating the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, & 5 of each cycle, in patients 61 years or older with acute myeloid leukemia (AML).

Principal Investigator: Jack Hsu, M.D. | Cell: 352-672-0704


A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial

A Phase 2, randomized study that investigates the use of the Signaterra ctDNA assay versus the standard scan-based approach to guide treatment in patients with metastatic colorectal cancer. The aim of this study will be to measure and compare the overall survival, progression-free survival, and best overall response while on study of patients whose treatment has been guided by these two approaches.

Principal Investigator: Sherise Rogers, M.D. | Cell: 718-614-5727 


A Dose Finding Phase 1 of Sarilumab plus Capecitabine in HER2/neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab plus Capecitabine in Stage I-III Triple Negative Breast Cancer with High-Risk Residual Disease

Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. This study will advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. 

Principal Investigator: Karen Daily, DO | Cell: 352-222-1423


Study of JTX 8064 in Combination with a PD-1 Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumors

A Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of JTX-8064.  JTX-8064 is a humanized mAB designed to block interaction of LILRB2 with its known ligands, and is administered IV in combination with a PD-1 inhibitor every 3 weeks. Cohorts are available for Squamous Cell Head and Neck cancer, platinum-resistant Ovarian cancer, Non-Small Cell Lung cancer, Cutaneous Squamous Cell Carcinoma, Undifferentiated Pleomorphic Sarcoma, and Liposarcoma.  

Principal Investigator: Thomas George, M.D. | Cell: 352-339-6672