Clinical Trials

The purpose of this stduy tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.

This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.

Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, common iliac, obturator packet, retropubic and sacral.  Following surgery there will be an expert pathologic review of the sampled lymph nodes by a dedicated GU pathologist and a corresponding comparison with preoperative imaging and patient risk AUA prostate cancer risk score. 

Following surgery, participants will visit the study doctor for their standard follow-up visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months with corresponding PSA surveillance with adjuvant imaging or treatment as part of standard of care.

Proposed study is intended to be carried out at the Mayo Clinic in Jacksonville, Florida. Urologist Dr. Ram Anil Pathak will be the responsible Principal Investigator, primary surgeon, and counselor for the study patients. The PI and his assigned team will conduct the follow-up visits (6 weeks, 3-, 6-, 9- and 12-months) at the Urology Clinic of Mayo Clinic in Florida.

Patients will be assessed for safety by regular evaluation of adverse events (AE) as clinically indicated.

Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment.  This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies.  There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective.  The primary goal of this randomized, phase III study is to determine the efficacy of ginseng in patients with cancer, who suffer from significant fatigue.

This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.

The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

The purpose of this study is to assess how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in this trial.  Patients will receive VSL#3® 450B sachets probiotics, which will be provided as part of this trial, at least 3 days but preferably 1-2 weeks prior to starting on ICIs. Patients will be followed per standard of care during ICI treatment and continue VSL#3 for 12 more weeks while on ICI. Patients will complete dietary questionnaire and have research blood draws and stool collections at baseline prior to starting VSL#3 and 3 additional time points. Adherence to the probiotic schedule will be captured in a study diary.  Adverse events as well as incidence and severity of IIC will be graded using NCI CTCAE version 5. Patients will have imaging performed per standard of care.

Primary Goal

• To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-CTLA-4 +/- anti-PD-1/PD-L1, and (2) anti-PD-1/PD-L1 +/- chemo.  

Secondary Goals

• To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.
• To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.

Exploratory Goals

• To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.
• To evaluate changes in immune response with ICIs and multi-strain probiotic blend.

The purpose of this study is to demonstrate non-inferiority of pCR with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.

The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL. 

The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.