Clinical Trials Search at Vanderbilt-Ingram Cancer Center
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
De vis, Jill
NCT05996432
VICC-EDMDT23195
Educational Telehealth Program for the Delivery of Care to Cancer Patients in Rural Communities, ENCORE Study
Miscellaneous
Miscellaneous
This clinical trial evaluates the clinical effectiveness of a multi-level telehealth-based intervention for cancer patients in rural communities. Rural residents face limited accessibility to cancer treatment and supportive care services, transportation barriers, and financial issues. Cancer Thriving and Surviving is an evidence-based self-management intervention with demonstrated efficacy across numerous chronic health conditions with dissemination across the US, inclusive of rural communities. This trial evaluates whether the evidence-based Cancer Thriving and Surviving intervention delivered through telehealth among rural patients may improve patient outcomes.
Miscellaneous
N/A
Friedman, Debra
NCT04758338
VICCPED2013
BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients
Supportive Care
Supportive Care
This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether
BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral
neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been
exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized,
placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label
BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.
BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral
neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been
exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized,
placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label
BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.
Supportive Care
Early I
Agarwal, Rajiv
NCT05291286
VICC-DTSUP23096
Vincristine Pharmacokinetics in Infants
Pediatrics
Pediatrics
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.
Pediatrics
N/A
Borinstein, Scott
NCT05359237
COGPEPN22P1
Evaluation of Patient Reported Outcomes in Patients with Digestive System and Lung Neuroendocrine Cancer, NET-PRO study
Gastrointestinal
Gastrointestinal
This study evaluates the patient reported outcomes in patients with digestive system neuroendocrine cancer and lung neuroendocrine cancer. Patients with neuroendocrine cancer usually have a high symptom burden which may have a negative effect on health-related quality of life (HRQoL). Patient questionnaires gather information describing symptoms and effect on quality of life, cancer type and any treatments received. Studying quality of life in patients receiving treatment for neuroendocrine cancers may help identify the effects of treatment and improve future treatment plans. Information gathered from this study may help researchers understand whether patient's diagnosis, symptoms, and order of cancer treatments have any effect on quality of life.
Gastrointestinal
N/A
Ramirez, Robert
NCT05064150
VICCGI2247
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
N/A
Kitko, Carrie
NCT04372524
VICCPED2183
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Miscellaneous
Miscellaneous
This is an observational case-control study to train and validate a genome-wide methylome
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
Miscellaneous
N/A
Rini, Brian
NCT05366881
VICCMD21111
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Multiple Cancer Types
In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use
in patients with TRK fusion cancer which is locally advanced or spread from the place where
it started to other places in the body. TRK fusion cancer is a term used to describe a
variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic
Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or
fuses, with a different gene. This joining results in the activation of certain proteins (TRK
fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an
approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult
and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the
decision to treat their disease with VITRAKVI has been made by their treating physicians.
During the study, patients' medical information such as treatment information with VITRAKVI,
other medication or treatments, changes in disease status and other health signs and symptoms
will be collected within the normal medical care by the treating doctor. Participants will be
observed over a period from 24 to 60 months.
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use
in patients with TRK fusion cancer which is locally advanced or spread from the place where
it started to other places in the body. TRK fusion cancer is a term used to describe a
variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic
Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or
fuses, with a different gene. This joining results in the activation of certain proteins (TRK
fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an
approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult
and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the
decision to treat their disease with VITRAKVI has been made by their treating physicians.
During the study, patients' medical information such as treatment information with VITRAKVI,
other medication or treatments, changes in disease status and other health signs and symptoms
will be collected within the normal medical care by the treating doctor. Participants will be
observed over a period from 24 to 60 months.
Pediatric Solid Tumors,
Pediatrics
N/A
Borinstein, Scott
NCT04142437
VICCPED2071
An Imaging Agent (Panitumumab-IRDye800) for the Detection of Head and Neck Cancer During Surgery
Head/Neck
Head/Neck
This phase II trial studies the effect of panitumumab-IRDye800 in detecting head and neck cancer during surgery in patients head and neck cancer. Doctors who perform surgery for head and neck cancer are well-trained in removing all of the cancer that can be seen during the operation; however, there are times when there is cancer that is so small that it cannot be seen by the surgeon. Panitumumab-IRDye800 is a combination of panitumumab and IRDye800CW. Panitumumab works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. IRDye800CW is an investigational dye that, when tested in the laboratory, helps various characteristics of human tissue show up better when using a special camera. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during the surgery. Giving panitumumab-IRDye800 may help doctors better identify cancer in the operating room.
Head/Neck
II
Rosenthal, Eben
NCT04511078
VICCHN21109
