Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This phase II trial investigates how well sacituzumab govitecan and atezolizumab work in preventing triple negative breast cancer from coming back (recurrence). Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the bodys natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help the immune system identify and catch tumor cells. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called SN-38. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers SN-38 to kill them. Giving sacituzumab govitecan and atezolizumab may work as a treatment for residual cancer in the breast or lymph nodes.

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.

This phase I/II trial studies the side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that cannot be removed by surgery and has not spread to other parts of the body (localized). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may work better than radiation therapy alone in the treatment of patients with localized pancreatic cancer.

This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patients weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.

This phase I trial evaluates the usefulness of an imaging agent (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing primary tumors and/or the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. 89Zr panitumumab is an investigational imaging agent that contains a small amount of radiation, which makes it visible on PET scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr panitumumab, to allow imaging of the function of different cells and organs in the body. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential disease tissue where it occurs in patients body. The combined PET/CT scanner is a special type of scanner that allows imaging of both structure (CT) and function (PET) following the injection of 89Zr panitumumab. This 89Zr panitumumab PET/CT may be useful in diagnosis of primary tumors and/or metastasis in patients with head and neck squamous cell carcinoma.

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.

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.