Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study
Breast
Breast
This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4/6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4/6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called autophagy to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the bodys immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseasesincluding cancers. One way the immune system controls the activity of T cells is through the PD-1/PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1/PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1/PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.
Breast
II
Reid, Sonya
NCT04841148
VICCBRE2161
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of
BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with
advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in
participants with advanced solid tumors.
BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with
advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in
participants with advanced solid tumors.
Not Available
I/II
Berlin, Jordan
NCT04895709
VICC-DTPHI23183
Evaluation of EBUS-TBNA versus EBUS-TBNA plus Transbronchial Mediastinal Cryobiopsy to Obtain Adequate Tissue Samples for Next Generation Sequencing, META-Gen Trial
This phase III trial compares how well endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) versus EBUS-TBNA plus transbronchial mediastinal cryobiopsy works to obtain adequate tissue samples for next generation sequencing (NGS). During usual care, if there is suspicion of cancer, a procedures known as an EBUS-TBNA is done to take sample of lymph nodes to evaluate for cancer spread. If there is suspected cancer in the lymph nodes, multiple samples are taken for molecular testing (NGS) to help guide treatment decisions. It requires a certain amount of tissue to send for the molecular testing which can be achieved with EBUS-TBNA about 70% of the time. Researchers want to find out if adding a biopsy tool currently used in usual care, known as a cryoprobe, can acquire more tissue for molecular analysis. The cryoprobe uses a freezing technique to biopsy and can potentially gather larger and higher quality tissue samples than the standard EBUS-TBNA method.
Not Available
III
Maldonado, Fabien
NCT06105801
VICC-VDTHO23177
Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
Head/Neck
Head/Neck
This clinical trial evaluates different nerve patterns to the throat muscles (stylopharyngeus and pharyngeal constrictor) and what they look like in different patients by measuring and photographing them in the neck during surgery when the nerves are dissected (separated into pieces) as part of regular surgical care. Researchers think that some of the muscles in the neck might be useful for treating a condition called obstructive sleep apnea (OSA). This happens when muscles of the throat relax at night and the airway becomes blocked. Blockage of airflow leads to drops in oxygen levels and can disturb sleep by forcing a persons brain to wake to restore airway muscles so they can breathe. This trial may help researchers provide a new way to treat OSA that may be better than the current standard ones.
Head/Neck
N/A
Ceremsak, John
NCT05754216
VICC-EDHAN23196
MRI and 18F-Fluoromisonidazole PET/CT Scan for Assessing Tumor Hypoxia and Guiding Adaptive Radiation Therapy in Patients With Head and Neck Cancer or Brain Metastases
Miscellaneous
Miscellaneous
This clinical trial is studying how well magnetic resonance imaging (MRI) in combination with 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans works in assessing a decrease in the amount of oxygen (hypoxia) in tumor cells and in guiding adaptive radiation treatment in patients with head and neck cancer or cancer that has spread to the brain from where it first started (brain metastasis). Both head and neck cancer and brain metastases can be treated with radiation. Previous research studies have shown that the amount of oxygen that goes towards cancer cells prior to their radiation treatments predicts how the cancer cells will respond to radiation treatment. MRI is a type of imaging technique that uses radio waves and large magnets to produce detailed images of areas inside the body. 18F-FMISO is a radioactive substance that binds to hypoxic tumor cells and emits radiation, allowing the tumor cells to be visualized using PET/CT, which is an imaging technique that combines PET and CT in a single machine. It is used to make detailed, computerized images of inside the body. By combining MRI with 18F-FMISO PET/CT, researchers may be able to develop an MRI sequence that can be used to evaluate hypoxia in tumor cells and predict response to treatment in patients with head and neck cancer or brain metastases.
Miscellaneous
Early I
Osmundson, Evan
NCT05996432
VICC-EDMDT23195
Impact of Indwelling Tunneled Pleural Drainage Systems (Gravity or Vacuum Based) on Pain in Patients with Recurrent Pleural Effusions
Lung
Lung
This trial studies the impact of indwelling tunneled pleural drainage systems (gravity or vacuum based) on pain in patients with plural effusion that has come back (recurrent). Vacuum drainage and gravity drainage are two commonly used drainage methods. Studying the best drainage methods may help future patients undergoing indwelling tunneled pleural catheter placement.
Lung
N/A
Maldonado, Fabien
NCT03831386
VICCTHO19118
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Multiple Cancer Types
The goal of this clinical study is to learn more about the long-term safety, effectiveness
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel,
KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored
interventional studies.
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel,
KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored
interventional studies.
Hematologic,
Leukemia,
Lymphoma,
Pediatric Leukemia,
Pediatric Lymphoma
N/A
Kassim, Adetola
NCT05041309
VICCCTT2170
Fluid Measurements and MRI in Determining Biomarkers of Lymphatic Dysfunction in Patients with Breast Cancer
Breast
Breast
This trial uses fluid measurements of the arm and MRI to determine biomarkers of lymphatic dysfunction in patients with breast cancer. Studying the lymphatic system (the part of your body that helps to process and clear waste products) in different ways will help doctors understand more about lymphedema (excess fluid after lymph nodes are removed) and help with prevention and management of lymphedema in patients with breast cancer.
Breast
N/A
Donahue, Manus
NCT03760744
VICCBRE18156
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Miscellaneous
Miscellaneous
This trial is being conducted to evaluate the efficacy of Phasix Mesh implantation at the
time of midline fascial closure compared to primary suture closure in preventing a subsequent
incisional hernia in subjects at risk for incisional hernia after open midline laparotomy
surgery.
time of midline fascial closure compared to primary suture closure in preventing a subsequent
incisional hernia in subjects at risk for incisional hernia after open midline laparotomy
surgery.
Miscellaneous
IV
Pierce, Richard
NCT03911700
VICCGI2281
Targeted Therapy Directed by Genetic Testing in Treating Patients with Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Not Available
II
Choe, Jennifer
NCT05564377
VICC-NTMDT23238
