Clinical trials

The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).

This is a phase I/II clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily accessible tumor for preparation of TIL. Eligible patients with progressive disease after standard of care therapy will undergo lymphodepletion with cyclophosphamide and fludarabine followed by CD40L-augmented TIL and standard of care bolus dose interleukin-2 (short-course IL-2).

This single-arm pilot study evaluates the feasibility and acceptability of a 4-week Mediterranean diet-based feeding intervention as nutritional prehabilitation for newly diagnosed, treatment-naïve breast cancer patients prior to surgery. All meals are provided to participants. Secondary aims include assessing changes in body composition, metabolic biomarkers, inflammation, gut microbiome composition, patient-reported outcomes, and clinician-reported surgical recovery metrics.

This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.

The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.

This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.

This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.

This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to make extinct, resulting in a cure for the patient. Such principles include an initial intense first strike to deplete the bulk of the cancer cells, followed by a series of sequential second strikes towards eliminating residual, resistant populations, followed by a prolonged period of maintenance chemotherapy to eliminate any remnant cells, using agents generally regarded to be active against newly diagnosed ES.

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.

The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for pancreatic cancer resection (removal).

Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.

This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.

This is a single-center, phase I/IB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at least two prior lines of skin-directed therapy (Stage IA-IB) or have less than a complete response to phototherapy or extracorporeal photopheresis (ECP) or total skin electron beam therapy (TSET), or stable/progressive disease after at least two lines of topical therapy (Stage IIA-IIIB).

The study aims to improve our understanding of how quality of life, fatigue, and symptoms change over 2 years when participants are treated for chronic lymphocytic leukemia or small lymphocytic lymphoma. We will compare two types of treatment to help future patients with chronic lymphocytic leukemia or small lymphocytic lymphoma know what to anticipate.

This is a single arm, open-label phase II study to assess the efficacy of single agent pembrolizumab for the treatment of advanced cutaneous sarcomas. Adult patients ≥18 years old who have been diagnosed with an advanced cutaneous sarcoma without regard to race, ethnicity, and/or gender. Approximately N=17 patients are planned to be enrolled. Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).

This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.

This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.

The purpose of the study is to refine, finalize, implement, and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.

The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.

This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.

Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN.