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
Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
This is a Phase II study to determine if a therapy designed for each individual tumor will improve recurrence and survival over standard of care. Patients with residual disease after neoadjuvant chemotherapy for triple negative breast cancer undergo genomic testing on the surgical specimen. Following post-op radiation, if indicated, patients receive 12-16 weeks of investigational adjuvant therapy versus standard of care, which may otherwise include observation or capectabine for 8 weeks.
Principle Investigator: Karen Daily, DO, cell: 352-222-1423
Phase II RCT of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Glioblastoma
This is a Phase II study to investigate newly diagnosed patients with glioblastoma. Patients will receive chemotherapy and radiation with randomization to one of three vaccine groups: placebo, pp65 CMV RNA dendritic cell vaccine using shLAMP or pp65 CMV RNA dendritic cell vaccine with flLAMP.
Principal Investigator: Maryam Rahman, MD, cell: 352-682-6717
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed/Refractory Multiple Myeloma (PANORAMA 3)
This is a Phase II study to investigate the safety and efficacy of three different regimens of panobinostat in combination with subcutaneous bortezomib and dexamethasone for patients with relapsed or relapsed/refractory multiple myeloma. Patients can only have received 1-3 prior lines of therapy, must have had prior IMiD exposure, and cannot be relapsed or refractory to bortezomib.
Principal Investigator: Jan Moreb, M.D., cell: 352-219-3787
Phase I/II Study of Rovalpituzumab Tesirine in Subjects with DLL3, Expressing Neuroendocrine Tumors
This is an open label study for metastatic and relapsed/refractory solid tumors that express DLL3 (most neuroendocrine tumors). Eight separate cohorts will enroll: malignant melanoma, medullary thyroid cancer, glioblastoma, large cell neuroendocrine carcinoma, neuroendocrine prostate cancer, high-grade gastroenteropancreatic, neuroendocrine carcinoma, other NEC, and solid tumors other than the above.
Principal Investigator: Frederick Kaye, M.D., cell: 352-672-8860
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
DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (SWOG1609)
This Phase 2 umbrella trial is a sister study to the NCI-MATCH but specifically for rare histologies (nearly 50 such diagnoses) in patients who have been screened with next generation sequencing for MATCH, but for whom do not have a molecular treatment match. Treatment for all such patients includes nivolumab and ipilimumab.
Principal Investigator: Thomas George, M.D., cell: 352-339-6672