Cancer Paid Clinical Trials in Alabama

The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year. Read Less

The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one. Read Less

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy. Read Less

Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy. Read Less

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 256 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks). Read Less

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy. Read Less

Many of the 2.8 million family caregivers (FCGs) of persons with advanced cancer are underserved, particularly African-Americans and rural-dwellers in the Southern U.S.. Most have poor access and awareness of community-based palliative care services and have received no formal support or training despite providing assistance to their relatives an average of 8 hrs/day. Providing intense care and witnessing a close friend or family member struggle with advanced cancer can result in FCGs experiencing marked distress, particularly as their care recipients near end of life (EOL). Reports from NCI and NINR caregiving summits, systematic reviews, and the National Academy of Medicine have highlighted major limitations of cancer caregiver interventions, including a lack of attention to underserved populations and cost, poor scalability, over reliance on highly-trained professionals (e.g., nurses, psychologists, behavioral therapists), lengthy sessions over a short duration, and a lack of demonstrated impact on patient outcomes and healthcare utilization. To address this gap, the investigators have developed and tested feasibility and acceptability of a lay navigator-led early palliative care intervention called ENABLE Cornerstone for rural and minority family caregivers of persons with advanced cancer in the Southern U.S.. Evolving out of the team's prior trials and community stakeholder formative evaluation work, this multicomponent intervention is based on Pearlin's Stress-Health Process Model where lay navigators, overseen by an interdisciplinary outpatient palliative care team, employ health coaching techniques and caregiver distress screening to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement. This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve family caregiver (Aim 1) and patient outcomes (Aim 2) and will evaluate implementation costs, cost effectiveness and healthcare utilization (Aim 3), over 24 weeks with 206 family caregivers and their patients with newly-diagnosed advanced cancer. To maximize recruitment, the investigators will recruit from two community cancer centers in Birmingham, AL and Mobile, AL. Our theory-driven, standardized approach is innovative because it uses lay navigators in collaboration with a palliative care interdisciplinary team to promote caregiver activation, skills and knowledge enhancement, as opposed to other difficult-to-implement intervention models that rely mostly on delivery of services by advanced practice professionals providing lengthy sessions over a short duration. If effectiveness is established, the ENABLE Cornerstone intervention offers a highly scalable and reproducible model of formal caregiver support that would be primed for dissemination and implementation. Read Less

The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE. Read Less

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v 1.1\]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo. Read Less

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Read Less

The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment. Read Less

This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC). Read Less