Clinical Corner
Bladder preservation therapy at UF Health
Access to clinical trials key to UF Health bladder preservation therapy
Patients facing a radical cystectomy after a diagnosis of bladder cancer can find themselves grappling with a diminished quality of life that threatens psychological and emotional well-being.
“Radical cystectomy impacts their ability to work,” said University of Florida Health urologic oncologist Paul Crispen, M.D. “It impacts their activity levels, sexual function and the way they eliminate urine from their body. This is a very morbid procedure that we only perform when absolutely indicated.”
It is with that patient in mind that the UF College of Medicine’s department of urology continues to develop new ways of treating this potentially life-threatening illness through bladder preservation.
UF Health physicians were among the pioneers in the field beginning in the 1980s under the leadership of Zev Wajsman, M.D., UF Health’s former chief of urologic oncology. Wajsman and his colleagues demonstrated that bladder preservation therapy is possible in select patients, especially when a multidisciplinary approach is taken.
“At UF Health, we’ve taken a particular interest in doing this in a multidisciplinary fashion with our urologists, medical oncologists and radiation oncologists,” said Crispen, an associate professor in the department of urology specializing in the surgical treatment of cancers of the bladder, kidney, prostate, testis and penis.
“We’re identifying newer therapies and patients who are able to undergo alternative therapies,” he added.
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Clinical Trial Highlight: Refractory Cancers
This issue of the UFHCC Connection highlights clinical trials currently recruiting patients with refractory malignancies.
Questions about how to send a patient? Please contact the Clinical Trials Office at cancer-center@ufl.edu or 352.273.8675
This Phase 1/2 non-randomized, open-label study is testing the orally administered AMG 510 in subjects with KRAS p.G12C mutant advanced solid tumors. Cohorts include NSCLC, CRC and other tumors. Treatment may include AMG 510 as monotherapy or in combination with pembrolizumab depending on the phase of the study at the time of subject enrollment. KRAS p.G12C mutation must be established through CLIA-approved molecular testing of the tumor, but additional biopsies for confirmatory testing may be required.
Principal Investigator: Thomas George, M.D., cell: 352.339.6672
This Phase 1b study aims to establish safety, tolerability, and tumor response of regorafenib in combination with pembrolizumab in patients with advanced HCC. Patients will have histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per AASLD criteria in patients with a confirmed diagnosis of cirrhosis, be BCLC stage B or C, and have a Child-Pugh Class A liver function status. Multikinase inhibitors (MKIs), such as regorafenib, may promote dendritic cell maturation, T cell priming, activation and differentiation into long-lived T cells by increasing tumor antigenicity and tumor immunogenicity as well as reducing inhibitory tumor-associated macrophage cells levels thereby reducing their immunosuppressive effects.
This is an investigator-initiated clinical trial that is based on the discovery of the importance of the Metnase complex in repairing chemotherapy-related DNA damage in leukemia. Ciprofloxacin has been identified as a metnase inhibitor that chemosensitizes leukemic myeloblasts to etoposide chemotherapy. The primary aims are to determine the maximum tolerated dose of ciprofloxacin that can be given in combination with a fixed dose of etoposide and determine the efficacy of the combination treatment in adults with resistant AML.
Principal Investigator: Randy Brown, M.D., cell: 859.221.6828