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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy versus Standard of Care Chemotherapy Alone for Patients with Unresectable Colorectal Liver Metastases: The PUMP Trial

This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
Not Available
III
Padmanabhan, Sekhar
NCT05863195
VICC-NTGIT23530

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

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

Enhanced Recovery After Surgery for Pain Management in Patients with Extremity Soft Tissue Sarcoma

Sarcoma

This clinical trial studies the effect of the ERAS pain management method in managing pain after surgery in patients with extremity soft tissue sarcoma. Enhanced Recovery After Surgery, or ERAS, is a pain management method that places emphasis on managing risk factors (things like smoking, nutrition and fitness), using multiple types of pain control, and early movement, with the goal of improving patient outcomes. ERAS has been shown to reduce the length of time some patients stay in the hospital, reduce complications from surgery, and even lower costs of some surgeries. ERAS is designed may help cut down on the use of these narcotics in managing the pain of surgery patients. The purpose of this trial is to demonstrate that ERAS is safe and effective for patients having surgery to treat their sarcoma. Specifically, this study will look at using a non-narcotic pain management program that includes other methods of managing the pain of sarcoma surgery patients.
Sarcoma
N/A
Lawrenz, Joshua
NCT04461171
VICCSAR2020

Studying the Effect of Levocarnitine in Protecting the Liver from Chemotherapy for Leukemia or Lymphoma

This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.
Not Available
III
Not Available
NCT05602194
VICC-NTPED23475

Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

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

Impact of Indwelling Tunneled Pleural Drainage Systems (Gravity or Vacuum Based) on Pain in Patients with Recurrent Pleural Effusions

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

Fluid Measurements and MRI in Determining Biomarkers of Lymphatic Dysfunction in Patients with Breast Cancer

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

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.
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

Multiple Cancer Types

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.
Breast, Gastrointestinal, Gynecologic, Head/Neck, Lung, Melanoma, Neuro-Oncology, Sarcoma, Urologic
II
Choe, Jennifer
NCT05564377
VICC-NTMDT23238

Neuroblastoma Maintenance Therapy Trial

Multiple Cancer Types

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter,
study for patients with neuroblastoma in remission. In this study subjects will receive 730
Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 250 mg/m2 BID (strata 1,
2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on
the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to
prevent recurrence.
Endocrine, Neuroblastoma (Pediatrics), Neuroendocrine, Pediatrics
II
Pastakia, Devang
NCT02679144
VICCPED16157

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