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 firstname.lastname@example.org or 352.273.8675
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Patients with non-muscle invasive localized bladder cancer that has not responded to treatment with Bacillus Calmette-Guerin (BCG) are treated with Atezolizumab (anti-PD-L1 antibody) to determine the response rate and survival. This agent has activity in advanced and metastatic disease.
Principal Investigator: Paul Crispen, MD, cell: 859.494.6157
Phase II Study of Niraparib In Patients with Advanced Uveal Melanoma, Renal Cell Carcinoma, Mesothelioma, Cholangiocarcinoma and Other Cancers with DNA Damage Response (DDR) Deficiencies
This open-label, single arm study is investigating the use of niraparib (an oral PARP inhibitor) in patients with tumors known to have mutations in BAP1 and a variety of other DNA damage response pathway genes. The primary aim is to determine the objective response rate of patients with BAP1 and other DDR repair pathway deficiencies. Cohorts include the histologies above (regardless of mutation) as well as any tumor histology with a confirmed DDR repair pathway mutation.
Principal Investigator: Thomas George, M.D., cell: 352.339.6672
Phase I/II Clinical Trial of Oral Ciproflaxacin and Etoposide in Subjects with Resistant Acute Myeloid Leukemia
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
Adjuvant Pembrolizumab in Patients with Triple-Negative Breast Cancer
This phase III RCT assigns triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy to one year of adjuvant Pembrolizumab versus standard of care. Adjuvant Capecitabine is allowed.
Principal Investigator: Karen Daily, DO, cell: 352.222.1423