JULY 2024 CLINICAL CORNER

Highlighted Clinical Trials Open for Enrollment

Ph2, Study to Assess the Safety and Efficacy of GPC 100 and Propranolol With and Without G-CSF for the Mobilization of Stem Cells in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

This is an open-label, Phase 1 trial evaluating the safety and efficacy of GPC-100 (Burixafor) and propranolol with G-CSF for the mobilization of stem cells in patients with Multiple Myeloma undergoing autologous stem cell transplant. Treatment will involve propranolol and G-CSF prior to stem cell mobilization. 

Principal Investigator: John Hiemenz, M.D.; Contact: 352-360-9811

Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors

This is a phase II multicenter study of Lutetium Lu 177 Dotate (Lu-177 Dotate) in combination with Triapine vs. Lu-177 Dotate alone in metastatic well-differentiated somatostatin receptor-positive neuroendocrine tumors, after the failure of at least one prior line of systemic treatment. Subjects will be randomized 1:1 to either Lu-177 Dotate w/ oral triapine vs. Lutathera alone.   Treatment is given in 8 week cycles, with IV Lu-177 Dotate on Day 1 of each cycle, with Triapine 150 mg QD Days 1-14.  Participants can receive up to 4 Cycles of treatment. 

Principal Investigator: Kathryn Hitchcock, M.D.

Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy for Limited mCRC (ERASur)

This phase III trial compares total ablative therapy (TAT) and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The ablative local therapy will consist of stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for Limited mCRC. This study is based on current common practice, and will pragmatically evaluate the safety, benefits versus risks, and survival impact of the integration of these treatments for Limited mCRC. 

Principal Investigator: Kathryn Hitchcock, M.D.

Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Principal Investigator: Thomas George, M.D., FACP, FASCO