CLINICAL CORNER

New Clinical Trials Open for Enrollment

The moment she opened her UF Health patient portal in September 2021, Dacia Starratt said she knew it was cancer. The word carcinoma seemed to jump off the screen in the biopsy results report. She kept her composure as she sat waiting for her 10-year-old son Luke at the Oceanway Sports Association on Jacksonville’s Northside while he finished practice.

The tumor in her breast was virtually undetectable to the touch, and Dacia had no symptoms. The suspicious growth was discovered during a routine mammogram and confirmed as breast cancer with a biopsy.

Dacia’s team of UF Health physicians – primary care, oncologist, surgeon, and radiation oncologist – coordinated her care and developed an optimal treatment plan to include a lumpectomy followed by 32 daily treatments of proton therapy.

When she rang Aud’s Chime in The Players Championship Lobby on February 23, 2022, not only did Dacia mark the end of her 6 weeks and 2 days of proton treatments, she also marked a major milestone of the UF Health Proton Therapy Institute as the 10,000th patient to complete treatment.


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