Selected Clinical Trials
Clinical Trials
The mission of the UF Health Cancer Center Clinical Trials Office (CTO) is to help deliver new and promising cancer treatments that improve the lives of our patients at the UF Health Cancer Center. The CTO provides support to our clinical investigators for the development and implementation of cancer clinical trials — facilitating the conduct of high-quality clinical research while adhering to the highest ethical standards and maintaining compliance with all governing bodies. This program will continue to undergo significant expansion over the next few years, as part of the initiative to become a National Cancer Institute-designated cancer center.
Currently, our clinical research program consists of the CTO and 11 disease-specific working groups (e.g., thoracic, GI, GU, neuro-oncology, hematologic malignancies). It also supports an Experimental Therapeutics Incubator for early-phase clinical trials that may have patient eligibility across several cancer types. Additionally, the Clinical Trials Office provides clinical trial support for outside institutions with affiliations through UF Health, the university’s academic health center.
Affiliate Clinical Research sites include:
- North Florida/South Georgia Veterans Health System (Gainesville, FL)
- Tallahassee Memorial Cancer Center (Tallahassee, FL)
- UF Health Proton Therapy Institute (Jacksonville, FL)
- Broward Health Medical System (Fort Lauderdale, FL)
UFHCC chosen for “unprecedented” pancreatic cancer clinical trials
The UF Health Cancer Center has been selected as one of 12 initial clinical trial sites participating in Precision Promise, the first large-scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer.
An initiative of the national nonprofit organization Pancreatic Cancer Action Network, Precision Promise is intended to dramatically accelerate the clinical trial process to bring promising therapies to patients faster.
“Being an inaugural member of the Precision Promise clinical trial consortium ensures that our patients have access to some of the most cutting-edge and innovative therapies available in the world for pancreatic cancer,” said Thomas George, M.D., the study’s principal investigator at UF and medical director of the GI Oncology Program. “The tools to help our patients fight pancreatic cancer and advance the field are now at our ready.”
Selected Clinical Trials
Brain and Nervous System
Phase: N/A
NCT02334722
Investigator: Maryam Rahman, M.D.
Study Title: A shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial
Phase: I/II
NCT02311582
Investigator: David Tran, M.D., Ph.D.
Study Title: A Phase I and Open Label, Randomized, Controlled Phase II Study Testing the Safety, Toxicities, and Efficacy of MK-3475 in Combination with MRI-guided Laser Ablation in Recurrent Malignant Gliomas
Phase: II
NCT01326104
Investigator: Duane Mitchell, M.D., Ph.D.
Study Title: Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy During Recovery from Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation
Phase: II
NCT02465268
Investigator: Maryam Rahman, M.D.
Study Title: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells with Tetanus-Diphtheria Toxoid Vaccine in Patients with Newly-Diagnosed Glioblastoma
Phase: II
NCT02663271
Investigator: David Tran, M.D., Ph.D.
Study Title: A Phase 2, Multi-center, Single arm, Histologically Controlled Study Testing the Combination of TTFields and Pulsed Bevacizumab Treatment in Patients with Bevacizumab-refractory Recurrent Glioblastoma
Breast
Phase: Pilot
NCT02199366
Investigator: Julie Bradley, M.D
Study Title: Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients with Left-Sided Breast Cancer Receiving Photon or Proton Therapy
Colon
Phase: III
NCT02664077
Investigator: Thomas George, M.D., FACP
Study Title: A Phase III Randomized Placebo-Controlled Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients with Stage III Colon Cancer (ARGO)
Gastrointestinal
Phase: II
NCT02921256
Investigator: Thomas George, M.D., FACP
Study Title: A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer
Head and Neck
Phase: II
NCT03077243
Investigator: Robert Amdur, M.D.
Study Title: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers
Phase: II
NCT02281955
Investigator: Robert Amdur, M.D.
Study Title: De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma
Hematologic/Bone Marrow Diseases
Phase: N/A
NCT02435550
Investigator: Christopher Cogle, M.D.
Study Title: iCare for Cancer Patients
Phase: N/A
NCT02927106
Investigator: Christopher Cogle, M.D.
Study Title: Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics
Phase: I
NCT02370888
Investigator: Maxim Norkin, M.D., Ph.D.
Study Title: A Phase I Clinical Trial to Evaluate the Maximally Tolerated Dose (MTD), Dose Limiting Toxicities (Dlts) and Safety Profiles of Increasing Doses of Lenalidomide After Allo-HCT in AML and MDS Subjects with Minimal Residual Disease (MRD) Detected by the CD34+ Mixed Chimerism Analysis
Phase: I/II
NCT02773732
Investigator: Randy Brown, M.D.
Study Title: A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects with Resistant Acute Myeloid Leukemia (AML)
Lung
Phase: I/II
NCT02920450
Investigator: Dennie Jones, M.D.
Study Title: A Non-Randomized Phase Ib-II Protocol of Paclitaxel, Carboplatin and the Dual PI3K/mTOR Kinase Inhibitor, PF-05212384, for Patients with Advanced, or Metastatic Non-Small Cell Carcinoma of the Lung (UF-STO-LUNG-002)
Phase: I/II
NCT01770418
Investigator: Bradford Hoppe, M.D.
Study Title: A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
Phase: II
NCT00875901
Investigator: Bradford Hoppe, M.D.
Study Title: Hypofractionated, Image-Guided Radiation Therapy with Proton Therapy for Stage I Non-Small Cell Lung Cancer
Phase: II
NCT02920476
Investigator: Dennie Jones, M.D.
Study Title: A Phase II Trial of TAS-102 (Lonsurf) in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung
Phase: II
NCT02146131
Investigator: Hiren Mehta, M.D.
Study Title: Multicenter, Prospective, Randomized Trial of Bronchoscopy with Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-Ebus) with Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (Fb) with Fluoroscopy for Biopsy of Pulmonary Lesions
Pancreatic
Phase: II
NCT02598349
Investigator: Romaine Nichols, M.D.
Study Title: A Phase II Trial of Escalated Dose Proton Radiotherapy with Elective Nodal Irradiation and Concomitant Chemotherapy for Patients with Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma
Prostate
Phase: II
NCT00969111
Investigator: Randal Henderson, M.D.
Study Title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
Sarcoma
Phase: II
NCT01871766
Investigator: Daniel Indelicato, M.D.
Study Title: Risk Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy
Phase: II
NCT02945800
Investigator: Joanne Lagmay, M.D.
Study Title: Phase II Study of Nab-Paclitaxel in Combination with Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults
Stem Cell Transplant
Phase: Pilot
NCT02326675
Investigator: Jamie Dees, R.N.
Study Title: Randomized Controlled, Open-Label Study on the Use of Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant Patients