Cancer

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases

   Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Rochester, Minn., Albert Lea, Minn.

   This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.

2. A Study of SGN-B7H4V in Advanced Solid Tumors

   Jacksonville, Fla.

   The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors.  A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.

3. Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

   Rochester, Minn.

   REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.

   The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.

   The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

4. IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

   Jacksonville, Fla.

   The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

5. A Study to Establish a Living Breast Organoid Biobank for Translational Research

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   Researchers at Mayo Clinic are developing a Biobank of adult stem cell-rich breast organoids, a new research resource to facilitate normal and cancer stem cell research. Subjects in the Biobank will provide samples of excess breast tissue, complete a health questionnaire, and allow access to medical records now and in the future. The Biobank serves as a library for researchers; instead of having to look for volunteers for each new project, researchers can use samples from the Biobank as well as share information already collected.

6. Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

   Rochester, Minn.

   99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.

7. Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.

    

    

8. A Clinical Use Application for the Humanitarian Use Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia

   Eau Claire, Wis.

   This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.

9. Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate

   Rochester, Minn.

   The purpose of this study is to develop tests for early detection of lung cancer (LC) based on multiomics analyses of patients’ breath condensates.  

10. A Study to Evaluate Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery

    Scottsdale/Phoenix, Ariz.

    The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.